Status:
ACTIVE_NOT_RECRUITING
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Lead Sponsor:
Axogen Corporation
Conditions:
Symptomatic Neuroma
Amputation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 amputati...
Eligibility Criteria
Inclusion
- Potential Subjects MUST:
- 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
- Potential Subjects MUST NOT:
- 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;
- 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;
- Have a history of idiopathic neuropathy/radiculopathy, known sciatica or chronic back pain;
- Documented history of centralized nerve pain that does not respond to a peripheral nerve block in the affected limb;
- Have a known allergy to anesthetic agents;
- Have a known sensitivity to porcine-derived products;
- Be currently enrolled or have been enrolled in another interventional clinical research study within the past 30 days (at time of consent); or
- Be deemed unsuitable for inclusion in the study at the discretion of the investigator.
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04865679
Start Date
March 2 2022
End Date
December 1 2026
Last Update
May 2 2025
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Texas Tech University, Health Science Center
Lubbock, Texas, United States, 79430