Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
Recruiting now · Not applicable
Conditions studied: Carpal Tunnel Syndrome (CTS)
In brief
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
Key facts
- Study ID
- NCT06593977
- Run by
- FzioMed
- People needed
- 50
- Starts
- 2026-03-26
- Expected to finish
- 2027-10-01
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed and dated informed consent form;
- Stated willingness to comply with all study procedures and availability for the duration of the study;
- Aged 18-65 years of age;
- In good general health;
- Patients experiencing recurrence or persistence of pain in the ipsilateral hand after previous carpal tunnel release for surgical treatment of primary carpal tunnel syndrome;
- All of the following physical examination tests must be performed; at least one must be positive:
- Physical examination demonstrates positive Phalen test;
- Physical examination demonstrates positive Tinel's test;
- Physical examination demonstrates positive monofilament test;
- ENMG demonstrates median nerve velocity and deviation consistent with the diagnosis of carpal tunnel syndrome.
You may not qualify if…
- Inability to understand the clinical trial and/or sign the Informed Consent;
- Unable or unwilling to attend all of the study prescribed visits and data collection forms;
- Active infection requiring medication;
- Drug requiring diabetes mellitus;
- Collagenopathies;
- Hypothyroidism requiring medication;
- Rheumatoid arthritis requiring medication;
- Autoimmune disease requiring medication;
- Cervical nerve compression;
- Hematopoietic disorders;
- Lacertus fibrosis;
- Psychiatric disorder requiring medical treatment;
- Subject of workers compensation claim;
- History of cancer, except for basal or squamous cell skin cancer;
- Known allergic reactions to components of DYNAVISC;
- Actively participating in another clinical trial.
Where it is running
- UZ Leuven — Leuven, Belgium, Belgium (enrolling)
- AZ Delta — Roeselare, Belgium, Belgium (enrolling)
- Hospital Angelina Caron — Araçatuba, Brazil, Brazil (enrolling)
- Azienda Ospedale Universita Padova — Padova, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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