Clinical trial NCT04865679: Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Official title: Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2021-04-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria: Potential Subjects MUST:

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: Potential Subjects MUST NOT:

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.

Primary outcomes:
measure: Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)
timeFrame: 15 Months
Secondary outcomes:
measure: Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline
timeFrame: Week 2, 1, 3, 6, 9 and 12 months
measure: 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
timeFrame: Week 2, 1, 3, 6, 9 and 12 months
measure: 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
timeFrame: Week 2, 1, 3, 6, 9 and 12 months
measure: Change in Brief Activities Measure for Adults with Upper Limb Amputation (BAM-ULA) through 12 post-operative months compared to baseline
timeFrame: 3, 6, 9 and 12 months
measure: Change in Timed Up and Go (TUG) Test for Lower Extremity Amputees through 12 post-operative months compared to baseline
timeFrame: 3, 6, 9 and 12 months
measure: Change in the 10-Meter Walk Test (10 MWT) for Lower Extremity Amputees through 12 post-operative months compared to baseline
timeFrame: 3, 6, 9 and 12 months
measure: Changes in quantity and class of pain medication use at week 2, 1, 3, 6, 9, 12, and 15 post-operative months comparted to baseline
timeFrame: Week 2, 1, 3, 6, 9, 12, and 15 months
Other outcomes:
measure: Nerve End Size Measurements
timeFrame: Prior to Secondary Surgery (if performed)
measure: Histological Assessment of Explanted Nerve Cap After Secondary Procedure
timeFrame: Following Explant (if performed)
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Lubbock
country: United States
facility: Texas Tech University, Health Science Center
state: Texas
Study officials:
References: