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

NCT04865679 | Active Not Recruiting FDA Device

• 2 other identifiers: CAP-CP-002CDMRP-OR180222
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

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

Keywords

Peripheral Nerve Injuries; Peripheral Nervous System Disease; Neuroma; Nerve Pain; Nervous System Diseases; Trauma - Nervous System; Amputation; Nerve Repair; Surgical Treatment of Pain

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)

  The primary safety endpoint will monitor the nature and incidence of AE's, SAE's and/or UADE's associated with an unplanned revision procedure prior to the planned Targeted Muscle Reinnervation (TMR) or Regenerative Peripheral Nerve Interface (RPNI) starting from implantation (operative day) through 15 months depending on whether or not the subject undergoes the secondary TMR or RPNI procedure.

  15 Months

Secondary Outcomes (7)

• Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline

  Week 2, 1, 3, 6, 9 and 12 months

• Change in Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures through TMR or RPNI procedure or 12 post operative months compared to baseline

  Week 2, 1, 3, 6, 9 and 12 months

• Change in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) through TMR or RPNI procedure or 12 post-operative months compared to baseline

  Week 2, 1, 3, 6, 9 and 12 months

• Change in Brief Activities Measure for Adults with Upper Limb Amputation (BAM-ULA) through 12 post-operative months compared to baseline

  3, 6, 9 and 12 months

• Change in Timed Up and Go (TUG) Test for Lower Extremity Amputees through 12 post-operative months compared to baseline

  3, 6, 9 and 12 months

Other Outcomes (2)

• Nerve End Size Measurements

  Prior to Secondary Surgery (if performed)

• Histological Assessment of Explanted Nerve Cap After Secondary Procedure

  Following Explant (if performed)

Study Arms (1)

Axoguard Nerve Cap®

EXPERIMENTAL

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

Device: Axoguard Nerve Cap®

Interventions

Axoguard Nerve Cap® DEVICE

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

Axoguard Nerve Cap®

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Texas Tech University, Health Science Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries; Peripheral Nervous System Diseases; Neuroma; Neuralgia; Nervous System Diseases; Trauma, Nervous System

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Wounds and Injuries; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: April 29, 2021
• Study Start: March 2, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)