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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromaix implantation | Experimental | Implantation of Neuromaix during an diagnostic nerve biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromaix | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| proof of safety of the medical device Neuromaix | The primary objective is the proof of safety of the medical device Neuromaix. key parameter: normal wound healing without complications | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness evaluation of the implant device Neuromaix | 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 | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Bozkurt, PD Dr. med. | Department of Plastic Surgery, Hand Surgery and Burn Center,University Hospital RWTH Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Plastic Surgery, Hand Surgery and Burn Center, University Hospital RWTH Aachen | Aachen | 52074 | Germany |
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| ID | Term |
|---|---|
| D004194 | Disease |
| D006987 | Hypesthesia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |