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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
Be older than 18 years old
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 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
2,533 Total Patients Enrolled
3 Trials studying Carpal Tunnel Syndrome
2,533 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
~64 spots leftby Jun 2025