Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix

Study Overview
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Brief Summary
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The aim of this study is the development and initial clinical application of the nerve guide Neuromaix in humans to provide evidence for the safety and performance of the device. Neuromaix is intended to be used as a guiding structure to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap.

Detailed Description
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The Neuromaix nerve guide is an absorbable implant composed of porcine collagen, used to bridge a peripheral nerve discontinuity, and to create a conduit for axonal growth across the nerve gap. Neuromaix provides a protective environment for peripheral nerve regeneration after injury. Neuromaix connects the proximal and distal ends of a transected nerve, allowing regenerating axons to grow through the scaffold, into the distal nerve tissue towards the target muscle or skin. Neuromaix is composed of two parts. The Epimaix part provides the structural characteristics needed to suture the nerve guide in place and to prevent ingrowth of scar tissue. The Perimaix part provides a structure that mimics endoneurial tubes, providing guidance for the regenerating axons while bridging the nerve gap.

Official Title
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Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix

Conditions
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Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy

Intervention / Treatment
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* Device: Neuromaix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both genders in the age between 18 und 70 years patients who are scheduled for a nerve biopsy Exclusion Criteria: alcohol-related polyneuropathy paraneoplastic polyneuropathy present: immunosuppressive therapy present: malignant tumor peripheral vascular diseases collagen diseases (e.g. existing keloid scars) patients with an increased wound healing disorder (e.g. diabetics) patients with chronic venous insufficiency (vein thrombosis, skin diseases) patients with coagulation and bleeding disorders (ASA- or Marcumar-patients) present: pregnancy HIV, Hepatitis B or Hepatitis C infection

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromaix implantation<br>Implantation of Neuromaix during an diagnostic nerve biopsy | Device: Neuromaix<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proof of safety of the medical device Neuromaix | The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness evaluation of the implant device Neuromaix | The secondary objective is the evaluation of the effectiveness of the Neuromaix implantation (Performance arm of study). key parameters: axonal regeneration and recovery of sensory function | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nerve biopsy, nerve regeneration, neuroma pain, loss of sensation