Mochida ReFeel for Digital Nerve Injuries
NCT07524465 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2026-08-24
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.
Conditions
- Digital Nerve Injury
- Nerve Reconstruction
Interventions
- DEVICE
-
ReFeel
ReFeel is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue. ReFeel is a device used in applications for patients with peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Sponsors & Collaborators
-
OrthoCarolina Research Institute, Inc.
lead OTHER
Principal Investigators
-
Glenn Gaston, MD · OrthoCarolina Research Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-15
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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