Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix

NCT ID: NCT01884376

Last Updated: 2015-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-05-31

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.

Conditions

Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neuromaix implantation

Implantation of Neuromaix during an diagnostic nerve biopsy

Group Type: EXPERIMENTAL

Neuromaix

Intervention Type: DEVICE

Interventions

Neuromaix

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmet Bozkurt, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen

Locations

Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen

Aachen, , Germany

Countries

Germany

Other Identifiers

10-009

Identifier Type: -

Identifier Source: org_study_id