New gel may offer relief for persistent carpal tunnel pain
NCT ID NCT06593977
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times
Summary
This study tests a gel called DYNAVISC placed around the nerve during repeat carpal tunnel surgery to see if it reduces pain and tingling better than standard surgery alone. About 50 adults with ongoing hand pain after a prior carpal tunnel release will take part. Results are measured by pain scores and hand function over 12 weeks after surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Delta
RECRUITINGRoeselare, Belgium, 8800, Belgium
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Azienda Ospedale Universita Padova
RECRUITINGPadova, Italy, 35128, Italy
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Hospital Angelina Caron
RECRUITINGAraçatuba, Brazil, 83430-973, Brazil
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UZ Leuven
RECRUITINGLeuven, Belgium, 3000, Belgium
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Three shots, one wrist: which injection best eases carpal tunnel?
- Scalpel vs sound waves: two carpal tunnel surgeries go head to head
- Can carpal tunnel surgery restore more than hand function?
- Does nerve healing keep pace with hand recovery after carpal tunnel surgery?
- Retraining the brain to ease carpal tunnel pain: a new approach put to the test
- Can a Two-Session acupuncture treatment match ten sessions for carpal tunnel?