NCT06071468

Registry of the Patient Experience for Carpal Tunnel Release

Registry of the Patient Experience for Carpal Tunnel Release (MISSION)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 2,000 (estimated)
• Sponsor: Sonex Health, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Multi-center study to collect large scale, multidimensional real-world data on patients undergoing carpal tunnel release (CTR).

Detailed description

Multicenter prospective Registry of patients with symptomatic carpal tunnel syndrome (CTS) treated (unilateral or simultaneous bilateral) by Ultrasound guided CTR (CTR-US), Endoscopic CTR (ECTR), or Open CTR (OCTR).

Conditions

• Carpal Tunnel Syndrome
• CTS

Interventions

Type	Name	Description
DEVICE	UltraGuideCTR (Device) with Ultrasound Guided Carpal Tunnel Release (CTR-US)	The UltraGuideCTR is a commercially available medical device specifically developed to facilitate CTR-US. The device is a single-use, hand-held device that is inserted into the carpal tunnel through a small (typically \< 5 mm) wrist incision using continuous US guidance. The working tip of the UltraGuideCTR consists of two inflatable balloons that border a centrally located, retractable retrograde cutting knife. When inflated with sterile saline, the balloons increase the diameter of the tip from 4 mm to 8 mm. After the tip is positioned within the transverse safe zone of the carpal tunnel, the balloons are inflated to create space in the carpal tunnel, the blade is activated, and the TCL is transected in a retrograde manner. Following TCL transection, the blade is recessed, the balloons deflated, and the device is removed. The TCL is probed to ensure a complete release. The entire procedure is performed using US guidance.
PROCEDURE	Endocscopic CTR	Endoscopic CTR makes one or two short incisions to introduce instruments for visualizing. The key procedural steps involved in Endoscopic CTR are listed below. 1. Following the delivery of anesthesia, the surgeon makes a small wrist incision (usually less than 1.5 cm), with or without a small palmar incision (usually less than 1.5 cm, depending on whether they are using a single portal or double portal technique, respectively. 2. A series of dilators and raspers are used to create space in the carpal tunnel and clear synovial tissue from the undersurface fo the TCL. 3. A camera attached to a narrow tube (endoscope) is inserted into the carpal tunnel. 4. The transverse carpal ligament (which forms the roof of the carpal tunnel) is identified. 5. Using specialized cutting instruments and endoscopic guidance, the surgeon transects the TCL. 6. Endoscopic visualization and/or probing are used to confirm a complete release. 7. The wound(s) is/are typically closed with sutures.
PROCEDURE	Open CTR	OCTR is the most commonly used CTR technique in the United States.The key procedural steps involved in OCTR are listed below. 1. Following the delivery of anesthesia, an incision is made in the palm directly over the carpal tunnel. 2. The surgeon cuts through the palmar fascia to identify the TCL. 3. The surgeon transects the TCL with a scalpel and/or similar cutting instruments. 4. The surgeon inspects the carpal tunnel to ensure proper decompression. 5. The wound is closed with sutures.

Timeline

• Start date: 2024-01-26
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-10-06
• Last updated: 2026-02-06

Locations

33 sites across 1 country: United States

Regulatory

• FDA-regulated device study