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

Exclusion Criteria

• •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 currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
• •15. Be deemed unsuitable for inclusion in the study at the discretion of the investigator.