Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix (PeRepair)

RWTH Aachen University

Status: Completed

Conditions: Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy

Treatments: Device: Neuromaix

Study type: Interventional

Funder types: Other

Identifiers

NCT01884376

10-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Neuromaix implantation

Experimental group

Description:

Implantation of Neuromaix during an diagnostic nerve biopsy

Treatment:

Device: Neuromaix