AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 65 YearsAllFzioMed
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • Dynavisc
๐Ÿ“

Where

4 sites
UZ Leuven
Leuven, Belgium
AZ Delta
Roeselare, Belgium
Hospital Angelina Caron
Araรงatuba, Brazil
Azienda Ospedale Universita Padova
Padova, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy