Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix (PeRepair)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01884376|
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 18, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy||Device: Neuromaix||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: Neuromaix implantation
Implantation of Neuromaix during an diagnostic nerve biopsy
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01884376
|Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen|
|Aachen, Germany, 52074|
|Principal Investigator:||Ahmet Bozkurt, PD Dr. med.||Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen|