Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Abstract
The primary objective of this study is to evaluate Axoguard Nerve Cap in large diameter sizes (5mm - 7mm) for protecting and preserving terminated large diameter nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible. The secondary objective of this study is to demonstrate proof-of-concept that large diameter nerve caps can prevent or reduce the formation of symptomatic neuromas in large diameter nerve endings after trauma or amputation when immediate attention to the nerve injuries is not possible. Study Aims: 1. Demonstrate safety of the Axoguard Nerve Cap from implantation through 15-months; (Safety Endpoint) 2. Demonstrate the role of Axoguard Nerve Cap in protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to these injuries is not possible by providing easier dissection and access to terminated nerve endings to optimize subsequent reconstructive procedures, if performed. (Primary End Point) 3. Demonstrate reduction or mitigation of nerve pain and its effect on limb function (as measured by BAM-ULA and/or Timed Up and Go and/or 10-meter walk test) associated with segmental nerve loss (Secondary End Point) 4. Determine recruitment feasibility and protocol refinement opportunities for next phase clinical studies of this new treatment.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2022
- Accession Number
- AD1199701
Entities
People
- Ivica Ducic
- Kyle Icke
- Ray A. Rivera