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NCT05405218 · ClinicalTrials.gov registry record · NA
Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)
A NA study of Carpal Tunnel Syndrome and CTS, sponsored by Sonex Health.
- Completed
- Registry status
- NA
- Development phase
- 122
- Enrollment target
- 12
- Study locations
NCT05405218: Completed NA study of Carpal Tunnel Syndrome and CTS, sponsored by Sonex Health.
NCT05405218 is a NA study of Carpal Tunnel Syndrome and CTS that has completed, run by Sonex Health. The registered enrollment target is 122 participants, below the 217-participant average among 21 other Carpal Tunnel Syndrome trials with a reported enrollment target (44% lower). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05405218, a NA study of Carpal Tunnel Syndrome and CTS, has completed, sponsored by Sonex Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 122 participants
- Enrollment target
- 12
- Study locations
Study Summary
Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
Primary Outcome
The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated a
Conditions Studied
Interventions
- DEVICE CTR with Ultrasound Guidance using the UltraGuideCTR device
- PROCEDURE mOCTR
Study Locations (12)
Missouri
- Midwest Orthopedic Group - Farmington
- Sano Orthopedics - Lee's Summit
- Washington University - St Louis
Indiana
- Tri-State Orthopaedics - Evansville
- Indiana Hand to Shoulder - Indianapolis
California
- Sierra Orthopedic Institute - Sonora
Florida
- Orthopedic Associates - Fort Walton Beach
Kansas
- Kansas Orthopaedic Center - Wichita
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Twin Cities Orthopedics - Plymouth
Mississippi
- University of Mississippi - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2022-08-08 |
| Est. Completion | 2024-03-30 |
| Phase | NA |
What the finished NCT05405218 record still lists
NCT05405218 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 21 other Carpal Tunnel Syndrome trials with a reported enrollment target (44% lower).
The record links to 3 conditions, with Carpal Tunnel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which CTR with Ultrasound Guidance using the UltraGuideCTR device is the first listed.
NCT05405218 lists 12 locations in 9 states (Missouri, Indiana, California).
Frequently Asked Questions
What is clinical trial NCT05405218 about?
NCT05405218 is a clinical study titled "Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)". Study to compare the safety and effectiveness of carpal tunnel release with ultrasound guidance (CTR-US) vs. mini-open carpal tunnel release (mOCTR) in patients with symptomatic carpal tunnel syndrome (CTS).
What is the current status of trial NCT05405218?
This trial is currently completed. It is a NA study. The enrollment target is 122 participants. The study started on 2022-08-08. Estimated completion is 2024-03-30.
What conditions does trial NCT05405218 study?
This clinical trial studies the following conditions: Carpal Tunnel Syndrome, CTS, Carpal Tunnel.
What interventions are being tested in trial NCT05405218?
The interventions under investigation include: CTR with Ultrasound Guidance using the UltraGuideCTR device (DEVICE), mOCTR (PROCEDURE).
Who is sponsoring clinical trial NCT05405218?
This trial is sponsored by Sonex Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05405218 being conducted?
This trial has 12 study locations across California, Florida, Indiana, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05405218's enrollment target sits among peer trials
122 10th of 21 higher than 12 of 21 other Carpal Tunnel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carpal Tunnel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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