Carpal Tunnel Syndrome (CTS)NCT06593977
Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
A study testing Dynavisc in people with Carpal Tunnel Syndrome (CTS), run by FzioMed at 4 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome (CTS)
- What is being tested?
- Dynavisc
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 26 Mar 2026to Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
Belgium2 sites, 2 recruiting
- Recruiting
UZ Leuven
Leuven, Belgium, 3000
Anna Tarasiuk, +32 016338827, orthopedie.research@uzleuven.be
- Recruiting
AZ Delta
Roeselare, Belgium, 8800
Delphine Delforce, +32 051236069, Delphine.delforce@azdelta.be
Brazil1 site, 1 recruiting
- Recruiting
Hospital Angelina Caron
Araçatuba, Brazil, 83430-973
Ana Faccioni, +41 9 91579795, ana.faccioni@gmail.com
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedale Universita Padova
Padova, Italy, 35128
Luca Folini, +39 0498 212633, luca.folini@aopd.veneto.it
About this study
Official title: A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
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
Read the detailed description
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 participants).
All participants will gently mobilize their wrist and fingers immediately following surgery and multiple times daily thereafter. Strenuous movements will be allowed beginning 6 weeks following surgery. Participant's hand will be evaluated at 1 week, 4 weeks, and 12-weeks following surgery.
Pain measurement will be recorded by participant using visual analog scale (VAS Score); hand function measurement will be recorded by participant using Disabilities of the Arm, Shoulder and Hand (Quick DASH Score); neuropathic pain will be measured by DN4 Score; median nerve recovery will be measured by electroneuromyography (sensory conduction speed and distal motor latency); and grip strength will be measured by dynamometer. This information will be obtained and recorded at baseline and at evaluations by a person blinded to treatment assignment.
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Being tested
- Dynavisc
- Keywords
- carpal tunnel, revision
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynaviscDevice
DYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.
| Study group | Role | What they receive |
|---|---|---|
| Control, standard of care | No intervention | Hypothenar fat pad flap protection of the median nerve following revision surgery for treatment of recurrent or persistent carpal tunnel syndrome |
| Treatment of recurrent or persistent carpal tunnel syndrome with use of Dynavisc | Active comparator | Following completion of the surgical repair including neurolysis in participants randomized to DYNAVISC, application of DYNAVISC (1 ml) over/around the median nerve, including repair site, will be performed by surgeon using the applicator provided with the product. Receives: Device: Dynavisc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using VAS
Change in pain and paresthesia will be determined by recording VAS Scores at baseline and each Visit following surgery up to 12 weeks following surgery. VAS Score is a 1-10 range, with 1 being the best result.
Measured: 12 weeks
Secondary outcomes (4)
Resumption of hand function using the Quick DASH Score.
Resumption of hand function following repair of persistent or recurrent carpal tunnel syndrome will be measured by participant using the Quick DASH Score.
Measured: 12 weeks
Grip strength of hand closing
Grip strength of hand closing is measured by participant using a Jamar Hand Dynamometer as recorded in kilogram-force (kgf).
Measured: 12 weeks
Improvement in nerve conduction and lateral deviation
Change in velocity of nerve conduction and lateral deviation will be measured by Electroneuromyography (ENMG).
Measured: 12 weeks
Evaluation of neuropathic pain using DN4 assessment
Change in neuropathic pain of the hand and fingers following repair of persistent or recurrent carpel tunnel syndrome will be performed by participant's scoring of DN4.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start26 Mar 2026
- Primary completionAug 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome (CTS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FzioMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gere M diZerega, MD, Study director, Fziomed Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593977
- Sponsor's protocol ID
- FZ-TN002
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator-Blinded, Randomized Evaluation of DYNAVISC in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT06593977
- Acronym / sponsor ID
- FZ-TN002
- Conditions
- Carpal Tunnel Syndrome (CTS)
- Keywords
- carpal tunnel, revision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- FzioMedIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 participants).
All participants will gently mobilize their wrist and fingers immediately following surgery and multiple times daily thereafter. Strenuous movements will be allowed beginning 6 weeks following surgery. Participant's hand will be evaluated at 1 week, 4 weeks, and 12-weeks following surgery.
Pain measurement will be recorded by participant using visual analog scale (VAS Score); hand function measurement will be recorded by participant using Disabilities of the Arm, Shoulder and Hand (Quick DASH Score); neuropathic pain will be measured by DN4 Score; median nerve recovery will be measured by electroneuromyography (sensory conduction speed and distal motor latency); and grip strength will be measured by dynamometer. This information will be obtained and recorded at baseline and at evaluations by a person blinded to treatment assignment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control, standard of care | No intervention | –Hypothenar fat pad flap protection of the median nerve following revision surgery for treatment of recurrent or persistent carpal tunnel syndrome |
| Treatment of recurrent or persistent carpal tunnel syndrome with use of Dynavisc | Active comparator | Device: DynaviscFollowing completion of the surgical repair including neurolysis in participants randomized to DYNAVISC, application of DYNAVISC (1 ml) over/around the median nerve, including repair site, will be performed by surgeon using the applicator provided with the product. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynaviscDYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product. | Device | Treatment of recurrent or persistent carpal tunnel syndrome with use of Dynavisc |
Primary outcome
Pain using VAS
Time frame: 12 weeks
Change in pain and paresthesia will be determined by recording VAS Scores at baseline and each Visit following surgery up to 12 weeks following surgery. VAS Score is a 1-10 range, with 1 being the best result.
4 secondary outcomes
Resumption of hand function using the Quick DASH Score.
Time frame: 12 weeks
Grip strength of hand closing
Time frame: 12 weeks
Improvement in nerve conduction and lateral deviation
Time frame: 12 weeks
Evaluation of neuropathic pain using DN4 assessment
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gere M diZerega, MD study director
Fziomed Inc.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynavisc in people with Carpal Tunnel Syndrome (CTS), run by FzioMed at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Brazil, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gere diZerega, MD (805-630-2800, gdizerega@fziomed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain using VAS (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.