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Nerve Protection Device
Axoguard Nerve Cap for Amputation Recovery (REPOSE-XL℠ Trial)
N/A
Recruiting
Research Sponsored by Axogen Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Present for surgery with a previous amputation and be undergoing surgery to address nerve ends
Be an adult male or female ≥ 18 and ≤ 80 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2, 1, 3, 6, 9, 12, and 15 months
Awards & highlights
REPOSE-XL℠ Trial Summary
This trial looks at whether a device called the Axoguard Large-Diameter Nerve Cap can help preserve nerve endings after limb trauma or amputation when immediate medical attention is not possible.
Who is the study for?
This trial is for adults aged 18-80 who have had limb trauma or amputation and are scheduled for nerve surgery within 6-12 months, or need surgery to address nerve ends. Participants must have a terminated nerve end between 4-7 mm in diameter and be able to cover it with the Axoguard Nerve Cap. They should not be undergoing treatments affecting neural growth, have uncontrolled diabetes, infections, allergies to anesthetics, sensitivity to porcine products, or other conditions that would exclude them.Check my eligibility
What is being tested?
The study tests the Axoguard Large-Diameter Nerve Cap (sizes 5-7 mm) on patients with limb trauma or amputations. It aims to protect and preserve terminated nerve endings when immediate repair isn't possible. The feasibility and tolerability of this device will be evaluated over time.See study design
What are the potential side effects?
While specific side effects are not listed for this pilot study, potential risks may include local irritation at the cap site, allergic reactions if sensitive to porcine-derived materials used in the cap, infection risk due to implantation of a foreign body, and general discomfort.
REPOSE-XL℠ Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had an amputation and am having surgery to treat my nerve ends.
Select...
I am between 18 and 80 years old.
Select...
I have enough soft tissue for proper coverage by the Axoguard Nerve Cap.
REPOSE-XL℠ Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2, 1, 3, 6, 9, 12, and 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 1, 3, 6, 9, 12, and 15 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety: Adverse Events (AEs), Serious Adverse Events (SAEs), or Unanticipated Adverse Device Effects (UADEs)
Secondary outcome measures
Amputation
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
Change in Timed Up and Go (TUG) Test for Lower Extremity Amputees through 12 post-operative months compared to baseline
+4 moreOther outcome measures
Histological Assessment of Explanted Nerve Cap After Secondary Procedure
Nerve End Size Measurements
REPOSE-XL℠ Trial Design
1Treatment groups
Experimental Treatment
Group I: Axoguard Nerve Cap®Experimental Treatment1 Intervention
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
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Who is running the clinical trial?
Axogen CorporationLead Sponsor
10 Previous Clinical Trials
5,573 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am immunosuppressed or will be receiving immunosuppressive therapy.I have had an amputation and am having surgery to treat my nerve ends.I have diabetes with an HbA1c of 8% or higher, or diabetic neuropathy near my amputation site.I am between 18 and 80 years old.I am willing and able to follow the study's treatment and check-up schedule.I experience numbness or pain in my hands/feet from past chemotherapy.I have a bone growth in my limb where the nerve cap will be placed that hasn't been treated.I have a nerve end between 4 and 7 mm wide after cleaning and stopping bleeding.I have enough soft tissue for proper coverage by the Axoguard Nerve Cap.I cannot have implants due to conditions affecting blood supply or healing.I have a history of unexplained nerve pain, sciatica, or chronic back pain.I am scheduled for nerve surgery after limb amputation within 6-12 months.I am currently receiving or will receive treatment that affects nerve or blood vessel growth.Your doctor thinks you have less than 15 months to live.I have had or will have radiotherapy on the end-neuroma area.You have a severe infection that is not under control.You are allergic to anesthesia.You are allergic to products made from pigs.I have nerve pain in my limb that didn't improve with a specific nerve pain treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Axoguard Nerve Cap®
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to participate in this clinical research program?
"In order to meet the criteria for this research, candidates must have had an amputation and be in the 18-50 age range. The investigation requires a total of 15 individuals."
Answered by AI
Is this research open to senior participants aged 75 and above?
"This trial is designed for participants 18 to 50 years of age. There are, however, 11 studies that cater to younger patients and 216 trials available for the elderly population."
Answered by AI
Is enrollment for this trial currently available to the public?
"According to clinicaltrials.gov, this study is presently recruiting patients with the first posting date of March 2nd 2022. The latest update was made on April 21st 2022."
Answered by AI
What is the total cohort size of this research initiative?
"Affirmative. Information hosted on clinicaltrials.gov indicates that this trial is currently recruiting participants, which was initially posted on March 2nd 2022 and last updated on April 21st 2022. 15 individuals are required from two different medical centres."
Answered by AI
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