Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix

Not Applicable

Completed

• Conditions: Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy
• Interventions: Device: Neuromaix

• Registration Number: NCT01884376
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-06-19
• Study First Submitted QC: 2013-06-19
• Study First Posted: 2013-06-24
• Study Start: 2013-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-17
• Last Update Posted: 2015-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neuromaix implantation	Neuromaix	Implantation of Neuromaix during an diagnostic nerve biopsy

Primary Outcome Measures

Name	Time	Method
proof of safety of the medical device Neuromaix	12 months	The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications

Secondary Outcome Measures

Name	Time	Method
effectiveness evaluation of the implant device Neuromaix	12 months	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

Trial Locations

Locations (1)

Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen; 🇩🇪 Aachen, Germany