Status:
COMPLETED
Clinical Study for the Treatment of Peripheral Nerve Defects With Neuromaix
Lead Sponsor:
RWTH Aachen University
Conditions:
Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy
Eligibility:
All Genders
18-70 years
Phase:
NA
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 intende...
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. Neurom...
Eligibility Criteria
Inclusion
- both genders in the age between 18 und 70 years
- patients who are scheduled for a nerve biopsy
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01884376
Start Date
July 1 2013
End Date
May 1 2015
Last Update
June 18 2015
Active Locations (1)
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1
Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen
Aachen, Germany, 52074