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

NCT ID: NCT04865679

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2026-12-31

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 amputation when immediate attention to the nerve injuries is not possible.

Conditions

Symptomatic Neuroma; Amputation; Chronic Nerve Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Axoguard Nerve Cap®

Active Comparator: Porcine derived extracellular matrix (ECM) based Nerve Termination Device

Implantation of appropriate diameter of Axoguard Nerve Cap® (sizes 5-7 mm) at the time of surgery

Group Type: EXPERIMENTAL

Axoguard Nerve Cap®

Intervention Type: DEVICE

Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Interventions

Axoguard Nerve Cap®

Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma

Intervention Type: DEVICE

Eligibility Criteria

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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axogen Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Texas Tech University, Health Science Center

Lubbock, Texas, United States

Countries

United States

Other Identifiers

CDMRP-OR180222

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAP-CP-002

Identifier Type: -

Identifier Source: org_study_id