Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting an… (NCT04865679) | Clinical Trial Compass
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Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
United States15 participantsStarted 2022-03-02
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Sign and date an IRB-approved written Informed Consent Form prior to initiation of any study procedures;
✓. Be an adult male or female ≥ 18 and ≤ 80 years of age;
✓. Present for surgery with either:
✓. 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;
✓. A previous amputation and be undergoing surgery to address nerve ends;
✓. 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;
✓. Have sufficient soft tissue available to be adequately covered by the Axoguard Nerve Cap;
✓. 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
✕. 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;
✕. Have signs and symptoms of chemotherapy-induced peripheral neuropathy from previous chemotherapy;
. Be immunosuppressed or have planned immunosuppressive therapy during the duration of the study;
✕. Current uncontrolled local or systemic infection as indicated by positive blood culture or other pathological indicators of infection;
✕. 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;
✕. Have a life expectancy of less than 15-months;
✕. Have a history of or be planning to undergo radiotherapy in the area of the end-neuroma;
✕. Have bony exostosis of the affected limb that is not treated at the time of nerve cap placement;