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

NCT06593977 | Recruiting FDA Device

• 1 other identifier: FZ-TN002
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 4

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

Conditions

Carpal Tunnel Syndrome (CTS)

Keywords

carpal tunnel; revision

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (4)

• Resumption of hand function using the Quick DASH Score.

  12 weeks

• Grip strength of hand closing

  12 weeks

• Improvement in nerve conduction and lateral deviation

  12 weeks

• Evaluation of neuropathic pain using DN4 assessment

  12 weeks

Study Arms (2)

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.

Device: Dynavisc

Interventions

Dynavisc DEVICE

DYNAVISC (1 ml) will be applied over/around the median nerve, including repair site, by the surgeon using the applicator provided with the product.

Treatment of recurrent or persistent carpal tunnel syndrome with use of Dynavisc

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• FzioMed: lead

Study Sites (4)

UZ Leuven

Leuven, Belgium, 3000, Belgium

RECRUITING

AZ Delta

Roeselare, Belgium, 8800, Belgium

RECRUITING

Hospital Angelina Caron

Araçatuba, Brazil, 83430-973, Brazil

RECRUITING

Azienda Ospedale Universita Padova

Padova, Italy, 35128, Italy

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Gere M diZerega, MD

  Fziomed Inc.

  STUDY DIRECTOR

Central Study Contacts

Gere diZerega, MD

CONTACT

805-630-2800; gdizerega@fziomed.com

Stephanie Cortese, MS

CONTACT

8054411968; scortese@fziomed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: March 26, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); BR (1); IT (1)