NCT07524465

Mochida ReFeel for Digital Nerve Injuries

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: OrthoCarolina Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Digital Nerve Injury
• Nerve Reconstruction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study