Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03758222




Registration number
NCT03758222
Ethics application status
Date submitted
26/11/2018
Date registered
29/11/2018
Date last updated
26/07/2022

Titles & IDs
Public title
Safety and Feasibility of the XFLO Expander System (Mercury)
Scientific title
A Clinical Study to Evaluate the Safety and Feasibility (Including First in Human) of the XFLO EXPANDER SYSTEM (EXPANDER-1)
Secondary ID [1] 0 0
PN-7585,-7998 10-MSC-1082
Secondary ID [2] 0 0
10-CIP-1164
Universal Trial Number (UTN)
Trial acronym
EXPANDER-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - XFLO Expander System

Experimental: Arm-1: Device implantation for 1 month - Treatment group receives intervention with the XFLO Expander System implantation for 1 month, and then retrieved.

Experimental: Arm-2: Device implantation for 6 months - Treatment group receives intervention with the XFLO Expander System implantation for 6 months, and then retrieved.

Experimental: Arm-3: Device implantation for 12 months - Treatment group receives intervention with the XFLO Expander System implantation for 12 months, and then retrieved.


Treatment: Devices: XFLO Expander System
Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [1] 0 0
1 month (Arm-1)
Primary outcome [2] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [2] 0 0
6 months (Arm-2)
Secondary outcome [1] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [1] 0 0
7 months (Arm-1)
Secondary outcome [2] 0 0
Freedom from Unanticipated adverse device effects (UADEs)
Timepoint [2] 0 0
12 months (Arm-2)
Secondary outcome [3] 0 0
Change in International Prostate Symptom Score (IPSS)
Timepoint [3] 0 0
1 month and 7 months (Arm-1)
Secondary outcome [4] 0 0
Change in International Prostate Symptom Score (IPSS)
Timepoint [4] 0 0
6 and 12 months (Arm-2)

Eligibility
Key inclusion criteria
* Male gender
* Age = 50 years
* Prostate volume 30 - 80 cc by Abdominal Ultrasound (AUS) or Trans Rectal Ultrasound (TRUS)
* Prostatic urethra length of 2.0-6.0 cm, as measured from bladder neck to verumontanum, using cystoscopy (or prostate length from bladder neck to external sphincter of 2.0-8.0 cm during screening visit, using ultrasound).
* Medication history

* Not on BPH related medication for the past 6 months.
* If on BPH related medication:

* On 5-alpha-reductase inhibitors (ARIs), the patient must be on the medication for at least 3 months with a stable voiding pattern
* On alpha-blockers, the patient must be on the medication for at least 3 weeks with a stable voiding pattern
* Patients with symptomatic BPH and related lower urinary tract symptoms (LUTS):

* With International Prostate Symptom Score (IPSS) > 13; Qmax < 12 mL/sec on a voided volume =125 mL; Post-void residual (PVR) < 250 mL; QoL score = 3
Minimum age
50 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous BPH procedure
* Median prostatic lobe or high bladder neck
* Urethral stricture, meatal stenosis, or bladder neck obstruction - either current, or recurrent requiring 2 or more dilatations
* Elevated Prostate Specific Antigen (PSA) = 10 ng/mL unless negative biopsy within last 6 months, or a positive biopsy showing cancer
* Cystolithiasis within the prior 3 months
* History of neurogenic bladder or urinary retention with PVR >1000mL.
* Serum creatinine >1.8 mg/dl or upper-tract disease which compromises renal function
* Current or recent Urinary Tract Infection (UTI) or disease
* Known allergy to nickel
* Life expectancy of less than 24 months
* Known coagulopathies or subject on anticoagulants or antiplatelets other than aspirin = 100 mg (unless antiplatelets are withheld minimum 3 days prior to procedure)
* Anticipated need for additional surgery or treatments for comorbidities during the study period.
* Current gross hematuria
* Other co-morbidities that could impact the study results
* Unable or unwilling to complete all required questionnaires and follow-up assessments
* Unable or unwilling to sign informed consent form
* Currently enrolled in any other investigational clinical research trial that has not completed the primary endpoint.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2025
Actual
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Australian Clinical Trials Pty Ltd - Wahroonga
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Canada
State/province [2] 0 0
Montréal
Country [3] 0 0
Georgia
State/province [3] 0 0
Tbilisi
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MedeonBio, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Henry Woo, MD
Address 0 0
Australian Clinical Trials Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03758222