Mochida ReFeel for Digital Nerve Injuries

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
OrthoCarolina Research Institute, Inc.
Study ID
NCT07524465
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Digital Nerve Injury
  • Nerve Reconstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change from Baseline in Static two-point discrimination [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OrthoCarolina Research InstituteCharlotteNorth Carolina28207
Caleb J Michalek, BS
[email protected]
704-323-3698
Joshua Steinkd, BS
[email protected]
704-323-2557
Glenn Gaston, MD (PRINCIPAL_INVESTIGATOR)

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OrthoCarolina Research Institute· Charlotte, NC

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