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Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
Sponsor: FzioMed
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
Official title: A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-03-26
Completion Date
2027-10
Last Updated
2026-04-06
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (4)
UZ Leuven
Leuven, Belgium, Belgium
AZ Delta
Roeselare, Belgium, Belgium
Hospital Angelina Caron
Araçatuba, Brazil, Brazil
Azienda Ospedale Universita Padova
Padova, Italy, Italy