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Completed

NCT Number: NCT01884376

Clinical Study for the Treatment of Peripheral Nerve Defects With 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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aachen, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromaix

Device

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

Klinische Interventionsstrategie Zur überbrückenden Behandlung Peripherer Nervendefekte Mit Neuromaix

Acronym: PeRepair

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jun 24, 2013
Registry last updated
Jun 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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