Mochida ReFeel for Digital Nerve Injuries

NCT07524465 | Not Yet Recruiting Phase 4 DMC FDA Device

• 1 other identifier: 9220 (ReFeel - 0001)
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ReFeel; Digital Nerve; Nerve Gap; Mochida; Nerve Reconstruction

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Static two-point discrimination

  Presented in millimetres and in ASSH designation (less than 6 mm 'normal', 6-10 mm 'fair', and 11 to 15 mm 'poor')

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Secondary Outcomes (5)

• Change in Visual Analog Scale (VAS)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months

• Water emersion testing

  2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months

• Physician Satisfaction Score

  Operative

• How many nerves were repaired with the provided graft sheet?

  Operative

• Change in Range of Motion (ROM)

  Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months

Study Arms (1)

ReFeel device

OTHER

Subjects who enroll in this study will receive ReFeel device for Digital nerve injury

Device: ReFeel

Interventions

ReFeel DEVICE

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.

ReFeel device

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Workers Compensation

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Study Officials

• Glenn Gaston, MD

  OrthoCarolina Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb J Michalek, BS

CONTACT

704-323-3698; caleb.michalek@orthocarolina.com

Joshua Steinke, BS

CONTACT

704-323-2557; joshua.steinke@orthocarolina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Nerve injury that requires surgical management using the ReFeel device.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

US (1)