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NCT04865679
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Conditions: Symptomatic Neuroma, Amputation, Chronic Nerve Pain
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 15
Sponsor: Axogen Corporation
Location: Massachusetts General Hospital Boston Massachusetts
Summary
This pilot study evaluates the tolerability and feasibility of the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) for protecting and preserving terminated nerve endings after limb trauma or amputation when immediate attention to the nerve injuries is not possible.
Eligibility Criteria
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 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.
Source: ClinicalTrials.gov (NCT04865679). StuddyBuddy aggregates publicly available trial information.
