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Procedure

Ultrasound-Guided Surgery for Carpal Tunnel Syndrome (ROBUST Trial)

N/A
Waitlist Available
Led By Ashley Pistorio, MD
Research Sponsored by Sonex Health, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical diagnosis of unilateral or bilateral idiopathic CTS
≥18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

ROBUST Trial Summary

This trial studied the effectiveness of using ultrasound to treat Carpal Tunnel Syndrome in an office setting.

Who is the study for?
This trial is for adults over 18 with Carpal Tunnel Syndrome (CTS) who've tried non-surgical treatments without success. They must have a CTS-6 score above 12, a median nerve area of at least 10 mm2 in the affected hand, and be able to complete surveys for two years using a smartphone or email. Exclusions include prior surgery on the wrist/hand (except minor procedures), infections, other conditions needing intervention, uncontrolled thyroid disease, pregnancy plans within two years, and inability to consent.Check my eligibility
What is being tested?
The ROBUST trial tests an office-based procedure called Ultrasound Guided Carpal Tunnel Release (CTR-US) on patients with symptomatic CTS. It's a single-arm study meaning all participants receive the same treatment without comparison to another group or placebo.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of ultrasound-guided carpal tunnel release may include discomfort at the site of treatment, swelling, bruising, infection risk and temporary nerve symptoms like tingling or numbness.

ROBUST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with carpal tunnel syndrome in one or both hands.
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I am 18 years old or older.

ROBUST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)
Secondary outcome measures
Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)
Device and/or Procedure Related Adverse Events
EuroQoL 5-Dimension 5-Level (EQ-5D-5L)
+5 more

ROBUST Trial Design

1Treatment groups
Experimental Treatment
Group I: CTR-USExperimental Treatment1 Intervention
Ultrasound Guided Carpal Tunnel Release (CTR-US)

Find a Location

Who is running the clinical trial?

Sonex Health, Inc.Lead Sponsor
3 Previous Clinical Trials
2,531 Total Patients Enrolled
3 Trials studying Carpal Tunnel Syndrome
2,531 Patients Enrolled for Carpal Tunnel Syndrome
Ashley Pistorio, MDPrincipal InvestigatorUniversity of Nevada, Las Vegas

Media Library

Ultrasound Guided Carpal Tunnel Release (CTR-US) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05675046 — N/A
Carpal Tunnel Syndrome Research Study Groups: CTR-US
Carpal Tunnel Syndrome Clinical Trial 2023: Ultrasound Guided Carpal Tunnel Release (CTR-US) Highlights & Side Effects. Trial Name: NCT05675046 — N/A
Ultrasound Guided Carpal Tunnel Release (CTR-US) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05675046 — N/A
Carpal Tunnel Syndrome Patient Testimony for trial: Trial Name: NCT05675046 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment of subjects in this research endeavor?

"To move this trial forward, 140 eligible individuals must take part. Bluegrass Orthopaedics (Lexington, Kentucky) and University of Nevada, Las Vegas (Las Vegas, Nevada) are just two sites that can provide recruitment services."

Answered by AI

How many locations are participating in the implementation of this trial?

"In addition to the existing 3 sites, this medical study is also running out of Bluegrass Orthopaedics in Lexington, Kentucky, University of Nevada Las Vegas in Las Vegas, Nevada and New Braunfels Orthopaedic Surgery and Sports Medicine in Texas."

Answered by AI

Are enrollment opportunities currently available for this trial?

"Affirmative. The clinical trial is still open according to information on clinicialtrials.gov which was first posted on February 16th 2023 and most recently updated the next day. 140 participants are being sourced from 4 distinct medical sites."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
Bluegrass Orthopaedics
New Braunfels Orthopaedic Surgery and Sports Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I have tried different way to help and nothing works. I am looking for relief for my carpal tunnel without having to do surgery. I hope a clinical trial will help. Thank you.
PatientReceived 1 prior treatment
Thee pain is excruciating. I have moderate to severe CTS in both hands. The pain and numbness is 24/7. I also worry that I have muscle damage because my muscles hurt and when pressing on the they hurt worse. I also have MS and pre diabetes. It is affecting my life tremendously.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long do the visits take and how often? Does the trial pay?
PatientReceived no prior treatments
~72 spots leftby Mar 2025