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

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ClinicalTrials.gov Identifier: NCT01884376
Recruitment Status : Completed
First Posted : June 24, 2013
Last Update Posted : June 18, 2015
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

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.


Condition or disease Intervention/treatment Phase
Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy Device: Neuromaix Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: Neuromaix implantation
Implantation of Neuromaix during an diagnostic nerve biopsy
Device: Neuromaix



Primary Outcome Measures :
  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 Outcome Measures :
  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




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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Germany
Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Ahmet Bozkurt, PD Dr. med. Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01884376     History of Changes
Other Study ID Numbers: 10-009
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: June 18, 2015
Last Verified: June 2015

Keywords provided by RWTH Aachen University:
nerve biopsy
nerve regeneration
neuroma pain
loss of sensation