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Status:

RECRUITING

Registry of the Patient Experience for Carpal Tunnel Release

Lead Sponsor:

Sonex Health, Inc.

Conditions:

Carpal Tunnel Syndrome

CTS

Eligibility:

All Genders

18+ years

Brief Summary

Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).

Detailed Description

Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or O...

Eligibility Criteria

Inclusion

  • Inclusion Criteria 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)\* 5. Confirmatory diagnostic testing in the target hand(s)\*:
  • CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
  • ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires
  • Note: An asterisk (\*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures.
  • Exclusion Criteria:
  • Patient meets any of the contraindications per Instruction For Use (IFU)
  • Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.

Exclusion

    Key Trial Info

    Start Date :

    January 26 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    December 31 2027

    Estimated Enrollment :

    2000 Patients enrolled

    Trial Details

    Trial ID

    NCT06071468

    Start Date

    January 26 2024

    End Date

    December 31 2027

    Last Update

    January 7 2026

    Active Locations (37)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 10 (37 locations)

    1

    The Orthopaedic Group P.C. (CTR-US)

    Foley, Alabama, United States, 36535

    2

    Phoenix Hand (CTR-US)

    Scottsdale, Arizona, United States, 85260

    3

    Orthopaedics Associates of Hartford (OCTR)

    Glastonbury, Connecticut, United States, 06033

    4

    Aventura Hand Center (CTR-US)

    Aventura, Florida, United States, 33180