Mochida ReFeel for Digital Nerve Injuries

Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Digital Nerve Injury; Nerve Reconstruction
• Intervention / Treatment: Device: ReFeel

Detailed Description

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.

Despite this common injury there is continued debate on the best treatment algorithm for digital nerve injuries. Digital nerve repair is usually not an option as the field of injury is too large for direct repair. Both conduits and nerve allograft have been used with varying success. Nerve conduits have traditionally been used for gaps less than 2 cm, with allograft for larger gaps.

ReFeel has received 510(k) clearance for a new alginate-based nerve cuff. We propose to conduct an Investigator-led Observational Clinical Research of ReFeel for patients treated with alginate nerve cuff to assess the clinical function following reconstruction.

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Caleb J Michalek, BS; Phone Number: 704-323-3698; Email: caleb.michalek@orthocarolina.com
• Study Contact Backup: Name: Joshua Steinke, BS; Phone Number: 704-323-2557; Email: joshua.steinke@orthocarolina.com

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute
      • Principal Investigator: Glenn Gaston, MD
      • Contact: Caleb J Michalek, BS; Phone Number: 704-323-3698; Email: caleb.michalek@orthocarolina.com
      • Contact: Joshua Steinkd, BS; Phone Number: 704-323-2557; Email: joshua.steinke@orthocarolina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• Workers Compensation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Visual Analog Scale (VAS)	Pain Score (1-10, 1 being the best and 10 being the worst pain)	Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Water emersion testing	Recommend patients submerge injured hand into water until other digits wrinkle. Report weekly if finger wrinkles like non-injured digits.	2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Physician Satisfaction Score	Scale 0-5, with 0 being very difficult and 5 being very Easy the best score	Operative
How many nerves were repaired with the provided graft sheet?	How many nerves were repaired with the provided graft sheet?	Operative
Change in Range of Motion (ROM)	Change in Range of Motion (ROM) of the injured digit, measured in degrees, from baseline	Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Investigators: Principal Investigator: Glenn Gaston, MD, OrthoCarolina Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ReFeel; Digital Nerve; Nerve Gap; Mochida; Nerve Reconstruction
• Other Study ID Numbers: 9220 (ReFeel - 0001)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be determined at a later date.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No