NCT05031338

Carpal Tunnel Release Using Ultrasound

Carpal Tunnel Release Using Ultrasound Patient Experience Registry

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 411 (actual)
• Sponsor: Sonex Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of the Carpal Tunnel Release Using Ultrasound registry (CiTRUS Registry) is to collect experience information from patients scheduled to undergo carpal tunnel release surgery with either the SX-One MicroKnife® with ultrasound guidance or the traditional mini-open technique without US guidance.

Detailed description

The CiTRUS registry is an observational study designed to better understand the overall patient experience following a carpal tunnel release surgery using either the SX-One MicroKnife with ultrasound guidance or the traditional mini-open technique without ultrasound guidance. The determination of which surgical technique to uses will be determined by the treating physician and the patient. The patient registry outcomes are intended to help direct future clinical care, educate patients with carpal tunnel syndrome, and design future research.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
DEVICE	Carpal Tunnel Release	Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.
PROCEDURE	Carpal Tunnel Release	Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.

Timeline

• Start date: 2021-07-02
• Primary completion: 2022-08-01
• Completion: 2022-08-15
• First posted: 2021-09-01
• Last updated: 2022-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study