Actively Recruiting
Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
Led by FzioMed · Updated on 2026-04-06
50
Participants Needed
4
Research Sites
79 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for the study duration
- Aged 18 to 65 years
- In good general health
- Experiencing recurrence or persistence of hand pain after prior carpal tunnel release surgery
- At least one positive physical exam test: Phalen, Tinel's, or monofilament test
- ENMG shows median nerve velocity and abnormalities consistent with carpal tunnel syndrome
You will not qualify if you...
- Unable to understand the trial or sign informed consent
- Unable or unwilling to attend all study visits and complete data forms
- Active infection needing medication
- Diabetes requiring medication
- Collagen disorders
- Hypothyroidism requiring medication
- Rheumatoid arthritis requiring medication
- Autoimmune disease requiring medication
- Cervical nerve compression
- Blood disorders
- Lacertus fibrosis
- Psychiatric disorder requiring treatment
- Subject of workers compensation claim
- History of cancer except basal or squamous cell skin cancer
- Known allergy to DYNAVISC components
- Currently participating in another clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
UZ Leuven
Leuven, Belgium, Belgium, 3000
Actively Recruiting
2
AZ Delta
Roeselare, Belgium, Belgium, 8800
Actively Recruiting
3
Hospital Angelina Caron
Araçatuba, Brazil, Brazil, 83430-973
Actively Recruiting
4
Azienda Ospedale Universita Padova
Padova, Italy, Italy, 35128
Actively Recruiting
Research Team
G
Gere diZerega, MD
CONTACT
S
Stephanie Cortese, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here