Mochida ReFeel for Digital Nerve Injuries
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-69
SponsorOrthoCarolina Research Institute, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- ReFeel
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov