Mochida ReFeel for Digital Nerve Injuries (NCT07524465) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Mochida ReFeel for Digital Nerve Injuries
United States5 participantsStarted 2026-05-01
Plain-language summary
This is an Investigator Led single-center, Prospective and Observational, Clinical Research Project. The specific aim of this study is to test/observe the safety and effectiveness of the ReFeel Device for Digital nerve injury in improving recovery time and outcomes. The primary objective of this study is to monitor clinical and surgical procedural outcomes for the use of ReFeel device.
Who can participate
Age range
18 Years – 69 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:
* Age 18-69 years
* Digital nerve injury in at least one digit requiring repair with a gap of 1-25mm
* Able to provide tension free end to end nerve coaptation
* Have uninjured contralateral or adjacent digit that is suitable to serve as a referenced digit for baseline functional assessments.
* Willing to comply with follow up for visits up to 12 months.
Exclusion Criteria:
* Estimated distance of recovery greater than 150 mm (from proximal site of to the tip of the digit)
* Injury distal to distal interphalangeal joint
* Extensive soft tissue injury that will impair recovery assessment
* Incomplete nerve transections
* Injury requiring replantation of the target digit
* Injuries to the affected nerve proximal to the superficial arch
* Nerve injuries \> 24 weeks after initial injury
* End to side nerve repair
* Injuries with vascular damage resulting in inadequate perfusion despite repair
* Subjects with type 1 diabetes or type 2 diabetes requiring regular insulin therapy
* Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other know treatment that affects the growth of neural and/or vascular system
* History of neuropathy, diabetic neuropathy, or another known neuropathy
* Excepted use of medication during the study that is known to impact nerve regeneration or cause peripheral neuropathy such as immunosuppressant's and Chemotherapeutic
* History of chronic ischemic condition of the upper extremity.
*…
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.
What they're measuring
1
Change from Baseline in Static two-point discrimination