NCT06593977 Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
| NCT ID | NCT06593977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | FzioMed |
| Condition | Carpal Tunnel Syndrome (CTS) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-03-26 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion criteria * 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: 1. Physical examination demonstrates positive Phalen test; 2. Physical examination demonstrates positive Tinel's test; 3. Physical examination demonstrates positive monofilament test; * ENMG demonstrates median nerve velocity and deviation consistent with the diagnosis of carpal tunnel syndrome. Exclusion criteria * 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.
Contact & Investigator
Gere M diZerega, MD
STUDY DIRECTOR
Fziomed Inc.
Frequently Asked Questions
Who can join the NCT06593977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Carpal Tunnel Syndrome (CTS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06593977 currently recruiting?
Yes, NCT06593977 is actively recruiting participants. Contact the research team at gdizerega@fziomed.com for enrollment information.
Where is the NCT06593977 trial being conducted?
This trial is being conducted at Leuven, Belgium, Roeselare, Belgium, Araçatuba, Brazil, Padova, Italy.
Who is sponsoring the NCT06593977 clinical trial?
NCT06593977 is sponsored by FzioMed. The principal investigator is Gere M diZerega, MD at Fziomed Inc.. The trial plans to enroll 50 participants.