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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03820947
Registration number
NCT03820947
Ethics application status
Date submitted
8/01/2019
Date registered
29/01/2019
Date last updated
4/06/2024
Titles & IDs
Public title
VenaSeal Spectrum: Global Post-Market Randomized Controlled Trial
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Scientific title
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSealâ„¢ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease
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Secondary ID [1]
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MDT18034
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Reflux
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - VenaSealâ„¢ Closure System
Treatment: Devices - Endothermal Ablation (ETA)
Treatment: Surgery - Surgical Stripping
Experimental: VenaSealâ„¢ Closure System - CEAP 2-5 subjects will be randomized to VenaSealâ„¢ Closure System vs. ETA or Surgical Stripping
Active Comparator: Endothermal Ablation (ETA) - CEAP 2-5 subjects will be randomized to either VenaSealâ„¢ Closure System or ETA
Active Comparator: Surgical Stripping - CEAP 2-5 subjects will be randomized to either VenaSealâ„¢ Closure System or surgical stripping (outside of the United States only)
Other: VenaSealâ„¢ Closure System VLU Study - CEAP 6 active leg ulcer subjects will not be randomized to a comparator, all subjects will be treated with VenaSealâ„¢ Closure System
Treatment: Devices: VenaSealâ„¢ Closure System
The VenaSealâ„¢ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
Treatment: Devices: Endothermal Ablation (ETA)
ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice.
Treatment: Surgery: Surgical Stripping
Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Venous treatment satisfaction questionnaire-early (VenousTSQe)(For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
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Assessment method [1]
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Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
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Timepoint [1]
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30 days
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Primary outcome [2]
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Venous treatment satisfaction questionnaire- status (VenousTSQs) (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
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Assessment method [2]
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Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
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Timepoint [2]
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30 days
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Primary outcome [3]
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Percentage of target vein treated (For Randomized studies, VenaSeal vs. ETA and VenaSeal vs. Surgical Stripping Study)
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Assessment method [3]
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Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
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Timepoint [3]
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Index procedure
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Primary outcome [4]
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Time to ulcer healing (For VLU study)
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Assessment method [4]
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Time to ulcer healing, calculated through healing confirmation and verified by an independent core laboratory.
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Timepoint [4]
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Index procedure through 12 months
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Secondary outcome [1]
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Anatomic closure of the primary target superficial truncal vein
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Assessment method [1]
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Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSealâ„¢ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
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Timepoint [1]
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6 months
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Secondary outcome [2]
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Time to return to work
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Assessment method [2]
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Timepoint [2]
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Through study completion, an average of 30 days
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Secondary outcome [3]
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Anatomic closure of primary target vein
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Assessment method [3]
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Measured via Duplex Ultrasound showing primary target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSealâ„¢ system and ETA procedures, or the absence of refluxing or residual primary target vein after surgical stripping procedures.
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Timepoint [3]
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30 days, and 12, 24, 36, 48 and 60 months (30 days and 12 months only for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [4]
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Anatomic closure of target vein
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Assessment method [4]
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Measured via Duplex Ultrasound showing target vein closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSealâ„¢ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
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Timepoint [4]
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30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [5]
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Technical success of each target vein
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Assessment method [5]
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Measured via Duplex Ultrasound showing target vein (including primary target vein) closure along the entire treated vein segment with no discrete segments of patency exceeding 5 cm after VenaSealâ„¢ system and ETA procedures, or the absence of refluxing or residual target vein after surgical stripping procedures.
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Timepoint [5]
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Index procedure
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Secondary outcome [6]
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Reintervention of any target vein
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Assessment method [6]
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Assessed via number of the target veins requiring retreatment.
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Timepoint [6]
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Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [7]
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Time to reintervention of any target vein
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Assessment method [7]
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Timepoint [7]
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Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [8]
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Adverse events (AEs) occurring in the target limb
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Assessment method [8]
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Adverse events occurring in target limb, evaluated from index procedure through 12 months are hypersensitivity to VenaSealâ„¢ adhesive, phlebitis, granuloma, endovenous glue induced thrombosis (EGIT) or endovenous heat induced thrombosis (EHIT), symptomatic deep vein thrombosis (DVT) events.
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Timepoint [8]
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Index procedure through 12 months
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Secondary outcome [9]
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Additional adverse events
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Assessment method [9]
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Additional adverse events that will be evaluated through 60 months are symptomatic pulmonary embolism (PE) and serious adverse events (SAEs).
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Timepoint [9]
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Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [10]
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Healthcare utilization measured by the number of each type of adjunctive treatment.
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Assessment method [10]
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Timepoint [10]
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Index procedure through 12 months
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Secondary outcome [11]
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Healthcare utilization measured by number of healthcare resources and other health related resources utilized for target limb venous reflux disease
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Assessment method [11]
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Timepoint [11]
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Index procedure through 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [12]
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Healthcare utilization measured by number of healthcare resources utilized for adverse events
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Assessment method [12]
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Timepoint [12]
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Index procedure through 60 months (through 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [13]
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For VLU study only: Healthcare utilization measured by number of ulcer related healthcare resources utilized
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Assessment method [13]
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Timepoint [13]
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Index procedure through 60 months
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Secondary outcome [14]
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Time to return to normal activities
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Assessment method [14]
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Timepoint [14]
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Through study completion, an average of 30 days
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Secondary outcome [15]
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Intra-procedural and post-procedural pain
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Assessment method [15]
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Determined by using numeric rating scale (NRS) with a scale of 0-10, with '0' indicating no pain and '10' indicating worst pain imaginable.
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Timepoint [15]
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Index procedure, and 7 days and 30 days
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Secondary outcome [16]
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Change in venous disease symptoms compared to baseline measured by the revised Venous Clinical Severity Score (rVCSS)
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Assessment method [16]
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rVCSS score ranges from 0 to 30, with higher score indicating severe venous disease.
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Timepoint [16]
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7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [17]
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Change in venous disease symptoms compared to baseline as measured by subject self-reporting symptoms
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Assessment method [17]
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Timepoint [17]
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7 and 30 days, and at 6, 12, 24, 36, 48, and 60 months (7 and 30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [18]
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Change in Aberdeen Varicose Vein Questionnaire (AVVQ) score compared to baseline
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Assessment method [18]
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The total score ranges from 0-100 points, with '0' point indicating the best quality of life and '100' points indicating worst quality of life.
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Timepoint [18]
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30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [19]
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Change in EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L) compared to baseline
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Assessment method [19]
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Items are scored on a 1-5 scale, 5 being a worse outcome. Each of the 5 dimensions are scored separately to obtain a 5-digit code which is converted into a standard value by country. Max & min values vary by country.
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Timepoint [19]
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30 days, and 6, 12, 24, 36, 48 and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [20]
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Change in the 36-Item Short Form Health Survey (SF-36) compared to baseline
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Assessment method [20]
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The total score ranges from 0 to 100, with higher scores indicating better general health perception.
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Timepoint [20]
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30 days, and 6 and 12 months
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Secondary outcome [21]
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Change in the Venous Dependent Quality of Life (VenousDQoL) compared to baseline
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Assessment method [21]
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Measured by 0-5 and 0-7 point (there are two scales in this questionnaire) Likert scale with higher score indicating worst outcome.
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Timepoint [21]
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30 days, and 6, 12, 24, 36, 48, and 60 months (30 days, 6 and 12 months for VenaSeal vs. Surgical Stripping Study)
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Secondary outcome [22]
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Provider experience evaluating overall satisfaction with the procedure
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Assessment method [22]
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Measured by a 5 point Likert scale ranging from 0-5, with 5 indicating the best outcome (extremely satisfied with the treatment).
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Timepoint [22]
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Index procedure
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Secondary outcome [23]
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For VLU Study: Ulcer recurrence on the target limb
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Assessment method [23]
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Timepoint [23]
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Following ulcer healing through 60 months
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Secondary outcome [24]
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For VLU study: Ulcer healing rate
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Assessment method [24]
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Timepoint [24]
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Index procedure through 24 months or until ulcer healing has been confirmed
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Secondary outcome [25]
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For VLU Study: Ulcer-free time
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Assessment method [25]
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Timepoint [25]
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Through 60 months
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Secondary outcome [26]
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For VLU Study: Venous treatment satisfaction questionnaire-early (VenousTSQe)
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Assessment method [26]
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Peri-procedural patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQe).
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Timepoint [26]
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30 days
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Secondary outcome [27]
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For VLU Study: Venous treatment satisfaction questionnaire- status (VenousTSQs)
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Assessment method [27]
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Patient satisfaction as measured by a validated, patient-centered venous treatment satisfaction questionnaire (VenousTSQs).
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Timepoint [27]
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30 days
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Secondary outcome [28]
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For VLU Study: Percentage of target vein treated
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Assessment method [28]
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Elimination of clinically relevant superficial truncal disease in each target vein at the time of index procedure as measured by the percentage of target vein length successfully treated.
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Timepoint [28]
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Index procedure
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Eligibility
Key inclusion criteria
1. Patient is =18 years of age
2. Patient has venous reflux in superficial truncal vein(s) (e.g., GSV, SSV, accessory
saphenous veins) with CEAP 2 (symptomatic) or CEAP 3, 4a, 4b, 5, 6, appropriate for
treatment, as confirmed by DUS
3. Eligibility for treatment:
- VenaSeal vs ETA Study: Patient is eligible for treatment with the VenaSealâ„¢
system and ETA
- VenaSeal vs Surgical Stripping Study: Patient is eligible for treatment with the
VenaSealâ„¢ system and surgical stripping
- VLU Study: patients should be eligible for treatment with the VenaSealâ„¢ system
4. Treatable refluxing segment of target vein(s) 10 cm in length or longer
5. Patient has a target vein diameter of =3 mm throughout the intended treated segment of
the target vein as measured by DUS while patient is standing
6. Patient is willing and capable of complying with specified follow-up evaluations at
the specified times
7. Patient has an ability to understand the requirements of the study and to provide
informed consent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Patient has a known history of allergic sensitivities (including but not limited to
cyanoacrylate adhesives), or any other condition, which in the opinion of the
investigator may make the patient more susceptible to cyanoacrylate adhesive
hypersensitivity
2. Patient has known deep vein obstruction in the target limb, as identified by the
site's standard of care
3. Patient has abnormal pulse exam or ABI <0.8
4. Patient has acute superficial thrombophlebitis
5. Patient requires any non-target vein treatments in the contralateral or ipsilateral
limb, or any other surgical procedure up tp 30 days pre-procedure and through 3 months
post-procedure
6. Patient has any co-morbid conditions, which in the investigator's opinion may
interfere with the patient's compliance with study visits and procedures, or may
confound interpretation of study data (e.g., congestive heart failure Class III and
IV, non-ambulatory patients, severe hepatic dysfunction, life expectancy < 1 year)
7. IFU contraindications:
- VenaSeal vs. ETA Study: Patient has VenaSealâ„¢ system and/or ETA product's IFU
contraindication(s)
- VenaSeal vs Surgical Stripping Study: Patient has surgical stripping and/or
VenaSealâ„¢ system IFU contraindication(s)
- VLU Study: Patient has VenaSealâ„¢ system IFU contraindication(s)
8. Patient is non-ambulatory
9. Patient is a female of childbearing potential who may be pregnant or breastfeeding at
the time of the index procedure
10. Patient belongs to a vulnerable population per investigator's judgment or patient has
any kind of disorder that compromises his/her ability to give written informed consent
and/or to comply with study procedures
11. Patient is currently participating in an investigational drug or device study when the
data collected could be conflicting or biased due to participation in another study
12. Patient has documented COVID-19 infection currently or within the past 3 months.
Patient is not completely recovered from past COVID-19 infection, per physician's
discretion.
13. VLU Study: Patient has target ulceration identified to be of non-venous etiology, as
confirmed by the independent core laboratory
14. VLU Study: Patient has target circumferential ulceration that cannot be captured in a
single photograph (any ulcer curvature around the leg that goes out of sight)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
506
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [2]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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4575 - Birtinya
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Recruitment postcode(s) [2]
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- Wollongong
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
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California
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Country [3]
0
0
United States of America
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State/province [3]
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Connecticut
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Country [4]
0
0
United States of America
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State/province [4]
0
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District of Columbia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Massachusetts
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Country [6]
0
0
United States of America
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State/province [6]
0
0
New York
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Country [7]
0
0
United States of America
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State/province [7]
0
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Ohio
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Country [8]
0
0
United States of America
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State/province [8]
0
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Texas
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Country [9]
0
0
United States of America
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State/province [9]
0
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Washington
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Country [10]
0
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Canada
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State/province [10]
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Ontario
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Country [11]
0
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France
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State/province [11]
0
0
DIjon Cedex
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Country [12]
0
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France
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State/province [12]
0
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Lyon
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Country [13]
0
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France
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State/province [13]
0
0
Toulouse
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Country [14]
0
0
Germany
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State/province [14]
0
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Halle
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Country [15]
0
0
Italy
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State/province [15]
0
0
Milano
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Country [16]
0
0
Italy
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State/province [16]
0
0
Padova
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Country [17]
0
0
Korea, Republic of
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State/province [17]
0
0
Seoul
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Country [18]
0
0
Netherlands
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State/province [18]
0
0
Arnhem
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Country [19]
0
0
Spain
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State/province [19]
0
0
Granada
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Country [20]
0
0
Spain
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State/province [20]
0
0
Madrid
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Country [21]
0
0
United Kingdom
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State/province [21]
0
0
Bedford
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Country [22]
0
0
United Kingdom
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State/province [22]
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Cambridge
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Country [23]
0
0
United Kingdom
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State/province [23]
0
0
Harrow
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Country [24]
0
0
United Kingdom
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State/province [24]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Medtronic Endovascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSealâ„¢
Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of
Early and Advanced Stage Superficial Venous Disease
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03820947
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Kathleen Gibson, MD
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Address
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Lake Washington Vascular, US
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Country
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Phone
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Fax
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0
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Email
0
0
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Contact person for public queries
Name
0
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Address
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Country
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0
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Phone
0
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03820947
Download to PDF