TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Digital Nerve Injury

Intervention / Treatment
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* Device: TISSIUM™ Nerve Coaptation Device


Participation Criteria
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Eligibility Criteria
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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. 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Digital nerve repair<br>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. | Device: TISSIUM™ Nerve Coaptation Device<br>* Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of complications (CIC) related to the investigational device | 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) | through 12-months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semmes-Weinstein monofilament (SWMF) for nerve functional recovery | Product performance will be assessed as functional nerve repair based on nerve functional recovery using Semmes-Weinstein monofilament (SWMF) at 6-months post-surgery | at 6 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve repair, digital nerve repair, digital nerve lesion, peripheral nerve injury, peripheral nerve lesion, peripheral nerve repair