RecruitingNot ApplicableNCT06593977

Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome

A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome


Sponsor

FzioMed

Enrollment

50 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Dynavisc for people with carpal tunnel syndrome (cts). The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEDynavisc

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

View Full Details on ClinicalTrials.gov

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NCT06593977


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