Ultrasound-Guided Surgery for Carpal Tunnel Syndrome

(ROBUST Trial)

Recruiting at 8 trial locations

Overseen By Amanda Maltzen

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Sonex Health, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ashley Pistorio, MD

Principal Investigator

University of Nevada, Las Vegas

Eligibility Criteria

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.

Inclusion Criteria

CTS-6 score >12 in target hand

I have been diagnosed with carpal tunnel syndrome in one or both hands.

Subject agrees to complete follow-up questionnaires over a 24-month period

Exclusion Criteria

Pregnant or planning pregnancy in the next 24 months

Inability to provide a legally acceptable Informed Consent Form and/or comply with all follow-up requirements

I have had carpal tunnel release surgery on the hand in question.

Treatment Details

Interventions

• Ultrasound Guided Carpal Tunnel Release (CTR-US) (Procedure)

Trial Overview 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.

Participant Groups

Group I: CTR-US Experimental Treatment 1 Intervention

Ultrasound Guided Carpal Tunnel Release (CTR-US)

Who Is Running the Clinical Trial?

Sonex Health, Inc.

Lead Sponsor

Trials

4

Recruited

2,700+