Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
NCT06593977 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-04-06
Summary
The trial will evaluate the efficacy of DYNAVISC in subjects with a diagnosis of persistent or recurrent carpal tunnel syndrome. This is a prospective, multicenter, randomized, evaluator-blinded clinical trial. Results will be stratified based on the method used for median nerve coverage: Group 1 (standard of care surgery followed by DYNAVISC surrounding the median nerve, n=25 participants), Group 2 (standard of care surgery followed by coverage of the median nerve with a hypothenar fat pad flap, n=25
Conditions
- Carpal Tunnel Syndrome (CTS)
Interventions
- DEVICE
-
Dynavisc
DYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.
Sponsors & Collaborators
-
FzioMed
lead INDUSTRY
Principal Investigators
-
Gere M diZerega, MD · Fziomed Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-26
- Primary Completion
- 2027-08-31
- Completion
- 2027-10-31
- FDA Device
- Yes
Countries
- Belgium
- Brazil
- Italy
Study Locations
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