Digital Nerve InjuryPhase 4NCT07524465
Mochida ReFeel for Digital Nerve Injuries
A Phase 4 study testing ReFeel in people with Digital Nerve Injury and Nerve Reconstruction, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Digital Nerve Injury, Nerve Reconstruction
- What is being tested?
- ReFeel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OrthoCarolina Research Institute
Charlotte, North Carolina, 28207
Caleb J Michalek, BS, 704-323-3698, caleb.michalek@orthocarolina.com
Joshua Steinkd, BS, 704-323-2557, joshua.steinke@orthocarolina.com
About this study
Official title: 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.
Read the 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
- Being tested
- ReFeel
- Keywords
- ReFeel, Digital Nerve, Nerve Gap, Mochida, Nerve Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReFeelDevice
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 group | Role | What they receive |
|---|---|---|
| ReFeel device | Other | Subjects who enroll in this study will receive ReFeel device for Digital nerve injury Receives: Device: ReFeel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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')
Measured: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes (5)
Change in Visual Analog Scale (VAS)
Pain Score (1-10, 1 being the best and 10 being the worst pain)
Measured: 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.
Measured: 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
Measured: Operative
How many nerves were repaired with the provided graft sheet?
How many nerves were repaired with the provided graft sheet?
Measured: Operative
Change in Range of Motion (ROM)
Change in Range of Motion (ROM) of the injured digit, measured in degrees, from baseline
Measured: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nerve injury that requires surgical management using the ReFeel device.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Gaston, MD, Principal investigator, OrthoCarolina Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524465
- Sponsor's protocol ID
- 9220 (ReFeel - 0001)
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: To be determined at a later date.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.
- ClinicalTrials.gov ID
- NCT07524465
- Acronym / sponsor ID
- 9220 (ReFeel - 0001)
- Conditions
- Digital Nerve Injury, Nerve Reconstruction
- Keywords
- ReFeel, Digital Nerve, Nerve Gap, Mochida, Nerve Reconstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nerve injury that requires surgical management using the ReFeel device.
| Arm | Type | Receives |
|---|---|---|
| ReFeel device | Other | Device: ReFeelSubjects who enroll in this study will receive ReFeel device for Digital nerve injury |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReFeelReFeel 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. | Device | ReFeel device |
Primary outcome
Change from Baseline in Static two-point discrimination
Time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Presented in millimetres and in ASSH designation (less than 6 mm 'normal', 6-10 mm 'fair', and 11 to 15 mm 'poor')
5 secondary outcomes
Change in Visual Analog Scale (VAS)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Water emersion testing
Time frame: 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Physician Satisfaction Score
Time frame: Operative
How many nerves were repaired with the provided graft sheet?
Time frame: Operative
Change in Range of Motion (ROM)
Time frame: Baseline, 2 weeks, 6 weeks, 12 weeks, 3 months, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided. To be determined at a later date.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Gaston, MD principal investigator
OrthoCarolina Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ReFeel in people with Digital Nerve Injury and Nerve Reconstruction, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caleb J Michalek, BS (704-323-3698, caleb.michalek@orthocarolina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Static two-point discrimination (time frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.