Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix (PeRepair)
Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aachen, Germany, 52074
- Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Neuromaix implantation
Implantation of Neuromaix during an diagnostic nerve biopsy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
proof of safety of the medical device Neuromaix
Time Frame: 12 months
|
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
Time Frame: 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 |
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ahmet Bozkurt, PD Dr. med., Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 10-009
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