Registry of the Patient Experience for Carpal Tunnel Release

Launched by SONEX HEALTH, INC. · Oct 4, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Registry of the Patient Experience for Carpal Tunnel Release, is studying the experiences of patients who are planning to have surgery for Carpal Tunnel Syndrome (CTS). The goal is to gather detailed information from a large group of patients about their experiences before and after the surgery. This will help researchers understand how well the surgery works and what patients go through during their recovery.

To participate, you need to be at least 18 years old and have been diagnosed with CTS in one or both hands. You should also have tried other treatments that didn't help. If you're chosen to join, you'll be asked to complete questionnaires about your health and recovery over the next two years. It's important to have a smartphone or email address to receive these questionnaires. The trial is currently looking for participants, and anyone interested should check if they meet the eligibility criteria. Your input could be valuable in improving treatment for others with this condition.

Gender

ALL

Eligibility criteria

• 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)\*:
• • 1. CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region)
• • 2. 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:
• • 1. Patient meets any of the contraindications per Instruction For Use (IFU)
• • 2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.