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Multicenter Prospective Trial of Office-based Carpal Tunnel Release With Ultrasound Guidance (ROBUST)

NCT05675046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2026-01-06

Study results available
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Summary

Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with Ultrasound Guided Carpal Tunnel Release (CTR-US) in an office-based setting.

Conditions

  • Carpal Tunnel Syndrome
  • CTS

Interventions

DEVICE

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Participants who were treated with the Carpal Tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in the ROBUST Study.

Sponsors & Collaborators

  • Sonex Health, Inc.

    lead INDUSTRY

Principal Investigators

  • Ashley Pistorio, MD · University of Nevada, Las Vegas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-16
Primary Completion
2023-09-24
Completion
2025-08-06
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 NCT05675046 on ClinicalTrials.gov