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

ACTIVE_NOT_RECRUITINGNA

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

NCT04865679•Axogen Corporation

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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;
+5 more criteria

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

Texas Tech University, Health Science Center

Lubbock, Texas, United States

Key Dates

Start Date

March 2, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

May 2, 2025

Enrollment

ESTIMATED participants

Conditions

Symptomatic NeuromaAmputationChronic Nerve Pain

Interventions

Axoguard Nerve Cap®

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Feasibility of Neural Feedback for Lower Limb Amputees

DExterous Hand Control Through Fascicular Targeting (DEFT) - (Human Subjects)

Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses

Evaluation of Myoelectric Implantable Recording Array (MIRA) in Participants With Transradial Amputation

Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project

Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees