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

NCT05675046 | Completed Results DMC FDA Device

• 1 other identifier: 90098-TP
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 7

Brief 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

CTS; Carpal Tunnel Syndrome

Keywords

Ultrasound Guided Carpal Tunnel Release; CTR-US; Office-Based; In Office; UltraGuideCTR

Outcome Measures

Primary Outcomes (1)

• Boston Carpal Tunnel Questionnaire - Symptom Severity Scale (BCTQ-SSS)

  The Boston Carpal Tunnel Questionnaire Symptom Severity Scale (BCTQ-SSS) is a Carpal Tunnel Syndrome specific questionnaire that has been shown to be highly reproducible, internally consistent, valid, and responsive to clinical change in Carpal Tunnel Syndrome (CTS) and subject status post-carpal tunnel release (CTR). The BCTQ consists of 11 symptom severity questions (BCTQ-SSS). Scoring for the BCTQ- SSS ranges from 1 to 5, with higher scores indicating more severe symptoms, and is calculated as the mean of each response. The mean change score in BCTQ-SSS from baseline and 3-month follow-up are reported. Negative change scores indicate decreased symptom severity and positive change scores indicate increased symptom severity. Bilateral patients with both hands treated are reported based on their averaged score.

  Baseline and 3 Months

Secondary Outcomes (8)

• Time to Return To Normal Daily Activities (RTA)

  3 Months

• Time to Return To Work Among Employed Subjects (RTW)

  3 Months

• Boston Carpal Tunnel Questionnaire - Functional Status Scale (BCTQ-FSS)

  Baseline and 3 Months

• Michigan Hand Questionnaire (MHQ)

  Baseline and 3 Months

• Numeric Pain Scale

  Baseline and 3 Months

Study Arms (1)

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

EXPERIMENTAL

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

Device: Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Interventions

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device DEVICE

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

Also known as: UltraGuideCTR

Carpal Tunnel Release with Ultrasound Guidance using the UltraGuideCTR device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age
• Clinical diagnosis of unilateral or bilateral idiopathic CTS
• CTS-6 score \>12 in target hand\*
• Median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region of the target hand measured by diagnostic ultrasound\*
• Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection)\*
• Subject agrees to complete follow-up questionnaires over a 24-month period
• Subject has a valid smart phone number and/or email address to receive and answer follow-up questionnaires

You may not qualify if:

• Prior surgery on the target wrist or hand with the exception of (a) trigger finger release or similar minor finger procedure (e.g., digital ganglion cyst removal, foreign body removal) that has clinically recovered, or release for DeQuervain's syndrome (1st dorsal compartment) that has clinically recovered\*
• History of prior surgical CTR in the target hand\*
• History of infection in the target hand\*
• History of prior surgery in the non-target hand, including CTR, within 3 months of enrollment or with persistent symptoms that interfere with normal daily activities or work at the time of consent
• Planned surgical or interventional procedure on the contralateral hand within 3 months of the target hand procedure date\*
• Corticosteroid injection in the target hand within 6 weeks of study procedure date\*
• Presence of additional process in the target hand requiring additional intervention beyond carpal tunnel release (e.g. neurolysis, mass removal, tenosynovectomy)\*
• Clinically significant degenerative arthritis of the upper limb (shoulder to hand) on the target side\*
• Clinically significant inflammatory disease (including tenosynovitis) of the upper limb (shoulder to hand) on the target side\*
• Clinically significant trauma or deformity of the upper limb (shoulder to hand) on the target side\*
• Clinically significant vascular disease (including Raynaud's phenomenon) of the upper limb (shoulder to hand) on the target side\*
• Clinically significant neurological disorder (including complex regional pain syndrome) of the upper limb (shoulder to hand) on the target side\*
• Systemic inflammatory disease (e.g., rheumatoid arthritis, lupus)
• Amyloidosis
• Chronic renal insufficiency requiring dialysis

Sponsors & Collaborators

• Sonex Health, Inc.: lead

Study Sites (7)

Orthopedic Associates

Fort Walton Beach, Florida, 32547, United States

Location

Vero Orthopaedics

Vero Beach, Florida, 32960, United States

Location

Georgia Hand, Shoulder & Elbow

Atlanta, Georgia, 30309, United States

Location

Bluegrass Orthopaedics

Lexington, Kentucky, 40509, United States

Location

University of Nevada, Las Vegas

Las Vegas, Nevada, 89128, United States

Location

The Bone & Joint Surgery Clinic

Raleigh, North Carolina, 27609, United States

Location

New Braunfels Orthopaedic Surgery and Sports Medicine

New Braunfels, Texas, 78130, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Results Point of Contact

• Title: Amy Stegner, Vice President Clinical Affairs
• Organization: Sonex Health, Inc.

astegner@sonexhealth.com

(888) 518-8780

Study Officials

• Ashley Pistorio, MD

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter prospective single-arm trial of subjects with symptomatic Carpal Tunnel Syndrome treated with the Carpal tunnel Release with Ultrasound Guidance procedure using the UltraGuideCTR device in an office-based setting.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: February 16, 2023
• Primary Completion: September 24, 2023
• Study Completion: August 6, 2025
• Last Updated: January 6, 2026
• Results First Posted: June 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)