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Registry of the Patient Experience for Carpal Tunnel Release | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITING

Registry of the Patient Experience for Carpal Tunnel Release

Registry of the Patient Experience for Carpal Tunnel Release (MISSION)

NCT06071468•Sonex Health, Inc.

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 Open CTR (OCTR).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Locations (33)

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

Foley, Alabama, United States

Phoenix Hand (CTR-US)

Scottsdale, Arizona, United States

Orthopaedics Associates of Hartford (OCTR)

Glastonbury, Connecticut, United States

Aventura Hand Center (CTR-US)

Aventura, Florida, United States

Orthopaedic Associates (CTR-US)

Fort Walton Beach, Florida, United States

Central Florida Orthopaedic Surgery Associates, P.L (CTR-US)

Lakeland, Florida, United States

Melbourne Hand Center (OCTR)

Melbourne, Florida, United States

Miami Hand Center (NHVP)

Miami, Florida, United States

The Orthopaedic Hand and Arm Center (CTR-US)

Miami Lakes, Florida, United States

Tri-State Orthopaedics (CTR-US)

Evansville, Indiana, United States

Key Dates

Start Date

January 26, 2024

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2027

Last Updated

February 6, 2026

Enrollment

2,000

ESTIMATED participants

Conditions

Carpal Tunnel SyndromeCTS

Interventions

UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)

DEVICE

Endocscopic CTR

PROCEDURE

Open CTR

PROCEDURE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Registry of the Patient Experience for Carpal Tunnel Release

Inclusion Criteria

Exclusion Criteria

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