Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends

Inclusion Criteria: Potential Subjects MUST: 1. Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures; 2. Be an adult male or female ≥ 18 and ≤ 80 years of age; 3. Present for surgery with either: 1. Limb trauma and/or planned amputation of a limb and be candidates who are planned for a secondary nerve surgery such as Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) procedures within 6-12 months from time of amputation, or; 2. A previous amputation and be undergoing surgery to address nerve ends; 4. Have at least one nerve end measuring greater than 4 mm and less than 7 mm in diameter after debridement and hemostasis of the proximal nerve stump; 5. Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap; 6. Be willing and able to comply with all aspects of the treatment and follow-up assessments and to return for all required study visits throughout the study duration. Exclusion Criteria: Potential Subjects MUST NOT: 1. Currently undergoing or are expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment that affects the growth of neural and/or vascular tissues; 2. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy; 3. Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study; 4. Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection; 5. Be contraindicated for soft tissue implants. This includes but is not limited to any pathology that would limit the blood supply to the target area or otherwise compromise healing; 6. Have a life expectancy of less than 15-months; 7. Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma; 8. Have bony exostosis of the affected limb that is not treated at the time of nerve cap placement; 9. Have uncontrolled Type 1 or Type 2 Diabetes Mellitus with HbA1c of 8% or greater or those with diabetic neuropathy in the target area or proximal to the amputation site; 10. Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain; 11. Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb; 12. Have a known allergy to anesthetic agents; 13. Have a known sensitivity to porcine-derived products; 14. Be …