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Trial of Ultrasound Guided Carpal Tunnel Release Versus Traditional Open Release (TUTOR)

NCT05405218 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-06-05

Study results available
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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).

Conditions

  • Carpal Tunnel Syndrome
  • CTS
  • Carpal Tunnel

Interventions

DEVICE

CTR with Ultrasound Guidance using the UltraGuideCTR device

Carpal Tunnel Release with Ultrasound Guidance using UltraGuideCTR device

PROCEDURE

mOCTR

Mini Open Carpal Tunnel Release

Sponsors & Collaborators

  • Sonex Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Kyle Eberlin, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-08
Primary Completion
2023-04-06
Completion
2024-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405218 on ClinicalTrials.gov