ReFeel Device for Nerve Damage

JS
Overseen ByJoshua Steinke, BS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: OrthoCarolina Research Institute, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a device called ReFeel to determine its effectiveness in aiding recovery from nerve damage in fingers. The focus is on enhancing recovery time and outcomes for individuals with digital nerve injuries requiring repair. Candidates with a nerve injury in one finger and a healthy finger for comparison may be suitable for this study. The trial will assess the effectiveness and safety of the ReFeel device over a year. As a Phase 4 trial, it involves an FDA-approved device and aims to understand how ReFeel can benefit more patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are expected to use medications that affect nerve regeneration or cause nerve damage, like immunosuppressants or chemotherapy drugs.

What is the safety track record for the ReFeel device?

Early clinical studies demonstrated promising safety results for the ReFeel device in patients with digital nerve injuries. All patients in these studies regained full function after using the device, and no severe side effects were reported. As this study is now in Phase 4, researchers have gathered extensive safety information from previous users. This extensive testing indicates that the device is safe for further use.12345

Why are researchers enthusiastic about this study treatment?

The ReFeel device is unique because it offers a novel approach to treating digital nerve injuries, which are typically addressed through surgical repair or conservative methods like physical therapy and pain management. Unlike these standard treatments, the ReFeel device leverages advanced technology to potentially enhance nerve regeneration and recovery directly at the site of injury. Researchers are excited about this treatment because it could accelerate healing and improve functional outcomes, offering hope for quicker and more effective recovery compared to traditional methods.

What evidence suggests that the ReFeel device is effective for digital nerve injury?

Research has shown that the ReFeel device effectively treats nerve injuries in fingers and toes. In studies, this device simplified nerve surgery and accelerated patient recovery. Participants healed more quickly, encountered fewer complications, and experienced better long-term outcomes. Animal studies support these findings, demonstrating good healing in nerve models. Overall, ReFeel has proven effective in aiding nerve repair and recovery.13678

Who Is on the Research Team?

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Glenn Gaston, MD

Principal Investigator

OrthoCarolina Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-69 who have a digital (finger) nerve injury needing repair with a gap of 1-25mm. Participants must have at least one healthy finger for comparison and be willing to attend follow-up visits for up to a year.

Inclusion Criteria

* 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.
I am between 18 and 69 years old.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ReFeel device for digital nerve injury

12 weeks
Visits at baseline, 2 weeks, 6 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months
Visits at 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • ReFeel

Trial Overview

The study observes the safety and effectiveness of the ReFeel device in helping people recover from finger nerve injuries that require surgical repair. It tracks recovery outcomes after using this device during surgery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ReFeel deviceExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials
37
Recruited
6,000+

Citations

NCT07524465 | Mochida ReFeel for Digital Nerve Injuries

The primary objective of this study is to monitor clinical and surgical procedural outcomes for the use of ReFeel device. Detailed Description.

Comparative evaluation of nerve repair and local tissue ...

This study investigates the in vivo performance of ReFeel® in a rat sciatic nerve model, evaluating its degradation profile, host response, and regenerative ...

ReFeel Device for Nerve Damage · Info for Participants

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 ...

Digital nerve injuries: a review of predictors of sensory ... - PMC

In this review, the type of operation for digital nerve repair does not influence sensory outcome. However, we verified outcome to be influenced by the patient ...

The effect of injury area on the success of treatment ...

This study shows that repairs in Zone 1 are more successful than those in Zone 2, thus revealing direct repair as a superior method for digital nerve injuries.

Treatment options for digital nerve injury: a systematic review ...

Our study demonstrated that the results of surgical treatment of digital nerve injury are generally satisfactory; however, no nerve repair method has absolute ...

NEON (Nerve rEpair Or Not) trial: a randomized controlled trial ...

Based on the available data from the NEON trial, there is no evidence to support the beneficial effect of suture repair over nerve alignment ...

Revealing digital nerve lesions–A comprehensive analysis ...

A total of 2089 finger nerve lesions were analyzed, with a majority of cases occurring in men. Most injuries97.4 % were caused by trauma, predominantly cut/ ...