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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/NCT04327154
Registration number
NCT04327154
Ethics application status
Date submitted
26/03/2020
Date registered
30/03/2020
Date last updated
7/06/2024
Titles & IDs
Public title
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
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Scientific title
A Prospective, Multicenter, Single-arm Clinical Trial Evaluating Safety and Performance of TISSIUMTM Nerve Coaptation Device for the Repair of Digital Nerve Discontinuities Where Gap Closure Can be Achieved by Flexion of the Extremity.
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Secondary ID [1]
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PF00004-DC-2002
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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:
Digital Nerve Injury
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - TISSIUM™ Nerve Coaptation Device
Experimental: Digital nerve repair - There is no comparator for this study. All patients are in the treatment allocated group for digital nerve repair with the TISSIUM™ Nerve Coaptation Device.
Treatment: Devices: TISSIUM™ Nerve Coaptation Device
Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.
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Intervention code [1]
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Treatment: Devices
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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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Cumulative incidence of complications (CIC) related to the investigational device
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Assessment method [1]
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CIC includes the occurrence of any of the following complications:
Infection
Chronic pain (defined as pain lasting more than 3 months) not otherwise specified
Excessive inflammation as determined by the investigator
Device extrusion
Symptomatic neuroma formation
Impaired wound healing (examples are dehiscence, pain, skin irritation, keloid, scar hypertrophy)
Allergic reaction to the constituent polymer of the investigational device
Serious Adverse Device Effect (SADEs)
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Timepoint [1]
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through 12-months post-procedure
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Secondary outcome [1]
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Semmes-Weinstein monofilament (SWMF) for nerve functional recovery
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Assessment method [1]
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Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery
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Timepoint [1]
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at 6 months post-procedure
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Eligibility
Key inclusion criteria
- Patient undergoing a repair of a proper digital nerve of the hand;
- 100% transection injury to the nerve under repair;
- Gap closure between the nerve ends can be achieved by flexion of the extremity without
excessive tension;
- Clean surgical wound with sufficient healthy soft tissue that enables primary closure
without adjunctive soft tissue procedures;
- Patient willing and able to provide a signed Patient Informed Consent Form;
- Patient willing and able to follow the study instructions and likely to complete all
required study procedures and visits.
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Minimum age
18
Years
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Maximum age
65
Years
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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
- Patient has a known allergy to the constituent polymer of the investigational device;
- Patient has a documented diagnosis of peripheral neuropathy;
- Patient has a history of neuropathic pain;
- Patient has a history of injury to the nerve being studied;
- Patient has is missing the contralateral digit or with a history of injury to the
contralateral digit (comparison control area);
- Patient is pregnant or nursing
- Any patient with a diagnosis of type 1 Diabetes Mellitus;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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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
16/12/2022
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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
15/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [2]
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Gold Coast University Hospital - Gold Coast
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Recruitment postcode(s) [1]
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4102 - Brisbane
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Recruitment postcode(s) [2]
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4215 - Gold Coast
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Tissium
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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
The purpose of this study is to collect initial safety and device performance data of the
TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the
hand in which there has been no substantial loss of nerve tissue. Additional clinical
measures that assess device performance, use, and patient reported outcomes will be collected
to guide future study design and potential device modifications.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04327154
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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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Randipsingh Bindra
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Address
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Gold Coast University Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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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/NCT04327154
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