Symptomatic NeuromaREPOSE-XL℠NCT04865679
Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
A study testing Axoguard Nerve Cap® in people with Symptomatic Neuroma and Amputation, run by Axogen Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Neuroma, Amputation, Chronic Nerve Pain
- What is being tested?
- Axoguard Nerve Cap®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Mar 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 15Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Texas Tech University, Health Science Center
Lubbock, Texas, 79430
About this study
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
- Being tested
- Axoguard Nerve Cap®
- Keywords
- Peripheral Nerve Injuries, Peripheral Nervous System Disease, Neuroma, Nerve Pain, Nervous System Diseases, Trauma - Nervous System, Amputation, Nerve Repair, Surgical Treatment of Pain
- Medical subject headings
- Peripheral Nerve Injuries, Peripheral Nervous System Diseases, Neuroma, Neuralgia, Nervous System Diseases, Trauma, Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Axoguard Nerve Cap®Device
Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Axoguard Nerve Cap® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10-centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".
Final VAS score will be collected either just prior to TMR or RPNI procedure or 12- months post op if subject will not undergo the secondary TMR or RPNI procedure
Measured: 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
The Patient Reported Outcome Measurement Information System (PROMIS®) - Pain Related Measures is a set of person-centered measures that evaluates and monitors a patient's physical health and pain. The pain related measures include domains evaluating fatigue, pain intensity, pain interference, sleep Disturbance, and Pain Behavior. Short forms containing fixed sets of 4-10 items or questions are included for each domain. All PROMIS scores are presented as T-scores where the T-score is the standardized score with a mean of 50 (range 20-80) and a standard deviation of 10. Higher scores indicate more of the concept being measured where sometimes the concept is desirable (e.g., physical function) and sometimes this it is undesirable (e.g., fatigue).
Final PROMIS® Pain Related Measure will be collected either just prior to TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure.
Measured: 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
In this study, the Work Productivity and Activity Impairment (WPAI:SHP) questionnaire is an instrument to measure impairments in both paid work and unpaid work (leisure/regular activities) due nerve injury post-surgical intervention. It measures (1) absenteeism (work time missed), (2) presenteeism (impairment at work / reduced on-the-job effectiveness), (3) work productivity loss (overall work impairment / absenteeism plus presenteeism), as well as the (4) impairments in unpaid activity because of nerve injury post-surgical intervention during the past seven days. Scores for these 4 measures are expressed as impairment percentages with higher percentage scores indicating greater impairment in than lower percentage scores.
Final WPAI:SHP will be collected either at the office visit following the TMR or RPNI procedure or 12-months post op if subject will not undergo the secondary TMR or RPNI procedure
Measured: 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
The BAM-ULA is a 10-item observational measure of activity performance. The 10 items are as follows: tuck a shirt in pants, lift a 20-lb bag, open a water bottle, remove a wallet from back pocket, replace the wallet in back pocket, take a gallon of water from the refrigerator and place on the counter (lift gallon jug), pour water from a gallon jug, brush or comb hair, use a fork, and open a door with knob. Items are scored with either a 0 (cannot complete all subtasks) or 1 (can complete all subtasks). Lower scores area associated with greater impairment of activity performance and higher scores are associated with less impairment of activity performance.
Measured: 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
An observational test used to evaluate functional mobility in terms of postural stability, gait, stride length, and sway. Patients wear their regular footwear and can use a walking aid. They are asked to sit in a chair, stand up from that chair, walk to a line on the floor (10 ft. away) at their normal pace, turn around, walk back to the chair at a normal pace, and sit down again.
Measured: 3, 6, 9 and 12 months
Change in the 10-Meter Walk Test (10 MWT) for Lower Extremity Amputees through 12 post-operative months compared to baseline
A performance measure used evaluate functional mobility and gait. It assesses walking speed in meters per second over 10-meter distance.
Measured: 3, 6, 9 and 12 months
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
Quantity and class of pain medication use for subjects who were implanted with the Axoguard Nerve Cap® will be captured during the following visits: Screening (baseline), 2-weeks, 1, 3, 6, 9, 12, and 15 months post-op for comparison to baseline.
Measured: Week 2, 1, 3, 6, 9, 12, and 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start2 Mar 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axogen Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865679
- Sponsor's protocol ID
- CAP-CP-002
- Other IDs
- CDMRP-OR180222
- Acronym
- REPOSE-XL℠
- Status last verified
- Jun 2026
- First submitted
- 22 Apr 2021
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Feasibility Pilot Clinical Study of a Large-Diameter Nerve Cap for Protecting and Preserving Terminated Nerve Ends
- ClinicalTrials.gov ID
- NCT04865679
- Acronym / sponsor ID
- REPOSE-XL℠ / CAP-CP-002
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Axogen CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axoguard Nerve Cap® | Experimental | Device: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Axoguard Nerve Cap®Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma | Device | Axoguard Nerve Cap® |
Primary outcome
Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)
Time frame: 15 Months
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.
7 secondary outcomes
Change in Visual Analog Scale (VAS) For Pain Score through TMR procedure or 12 post-operative months compared to baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 3, 6, 9 and 12 months
Change in the 10-Meter Walk Test (10 MWT) for Lower Extremity Amputees through 12 post-operative months compared to baseline
Time frame: 3, 6, 9 and 12 months
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
Time frame: Week 2, 1, 3, 6, 9, 12, and 15 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Neuroma
RecruitingObservational study
Evaluation of RPNI for Symptomatic Neuromas in Lower Limb Amputees
Symptomatic Neuroma, Phantom Limb Pain After Amputation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Axoguard Nerve Cap® in people with Symptomatic Neuroma and Amputation, run by Axogen Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs) (time frame: 15 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.