A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and A… (NCT07657182) | Clinical Trial Compass
RecruitingPhase 4
A Prospective, Randomized, Assessor-Blinded, Multicenter Study Comparing Avance Nerve Graft and Autograft for Functional Recovery Following Mixed and Motor Peripheral Nerve Reconstruction
United States178 participantsStarted 2026-06-12
Plain-language summary
This is a multicenter, 1:1 randomized, prospective, comparative study in participants requiring reconstruction of a mixed or motor nerve in the upper extremity. This study will consist of a screening visit, an operative visit, and 9 post-operative follow-up visits at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Be ≥ 18 years of age at the time of consent;
. Willing and able to comply with all aspects of the treatment and evaluation schedule over a 24-month duration;
. Provide documented Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent prior to initiation of any study procedures;
. Primary or secondary nerve injury repair with sural nerve autograft or Avance Nerve Graft for fully transected reconstruction of the following upper extremity mixed and/or motor nerve(s):
. Zone of injury of eligible nerve(s) resectable to healthy nerve both distally and proximally and within the anatomical regions of Inclusion Criterion #4;
. In study participants with multiple eligible nerve repairs, repair of all eligible nerves completed with the same study treatment, either Avance Nerve Graft or sural nerve autograft;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Measured nerve gap(s) following resection \> 25 mm;
. Nerve(s) repaired ≤ 120 days post injury;
Exclusion criteria
. Currently enrolled in another clinical study that may interfere with treatment, assessment of recovery, or participation in this study;
. Deformities or injuries of the limb, hand, or digits that affect both the primary and secondary assessments for eligible nerve repair(s);
. History of neuropathy of any etiology, diabetic neuropathy or any other known neuropathy including compressive/traumatic neuropathies affecting the target limb;
. History of progressive neurodegenerative or autoimmune disorder affecting peripheral nerve or motor function (e.g., amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease);
. History of chronic ischemic condition of the upper extremity;
. Expected use of medication during the study that is known to impact nerve regeneration or to cause peripheral neuropathy;
. Undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other known treatment which affects the growth of neural and/or vascular systems;
. Participant is unlikely to comply with all study requirements and standard medical care procedures for the duration of the study schedule;