Patients With a Scheduled (Diagnostic) Nervus Suralis Biopsy
Conditions
Keywords
nerve biopsy, nerve regeneration, neuroma pain, loss of sensation
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.
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.
Interventions
DEVICENeuromaix
Sponsors
RWTH Aachen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| proof of safety of the medical device Neuromaix | 12 months | The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effectiveness evaluation of the implant device Neuromaix | 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 |
Countries
Germany
Outcome results
None listed