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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;