NCT05675046

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Sonex Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 reporting the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).

Conditions

• Carpal Tunnel Syndrome
• CTS

Interventions

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

Timeline

• Start date: 2023-02-16
• Primary completion: 2023-09-24
• Completion: 2025-08-06
• First posted: 2023-01-09
• Last updated: 2026-01-06
• Results posted: 2025-06-03

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study