Active — Not RecruitingNot Applicable

Registry of the Patient Experience for Carpal Tunnel Release

United States2,000 participantsStarted 2024-01-26

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)

Timeframe: 24 Months

NCT IDNCT06071468

SponsorSonex Health, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-12-31