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

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen ByAshley Pistorio, MD

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.

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.

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: CTR-USExperimental Treatment1 Intervention

Ultrasound Guided Carpal Tunnel Release (CTR-US)