First Patient Enrolled in Carpal Tunnel Release Treatment Study

Sonex Health Inc. and The Institute of Advanced Ultrasound Guided Procedures have initiated its MISSION trial (Post-Market RegIStry of the Patient Experience when uSing UltraGuIdeCTR fOr Carpal TuNnel Release), which aims to assess carpal tunnel treatment. Stuart Hilliard, M.D., of the North Texas Hand Center, enrolled the first trial patient.
 
MISSION is designed to be the largest U.S. multi-center clinical study of its kind. It will collect real-world, long-term data on carpal tunnel syndrome (CTS) patients treated with a carpal tunnel release (CTR) procedure using Sonex Health’s device—UltraGuideCTR—which employs real-time ultrasound guidance (CTR-US).
 
“Participating in this study is in direct alignment with how I practice medicine,” Hilliard said. “I believe in ensuring my patients are both knowledgeable about their condition and fully informed of the surgical and nonsurgical options to better involve them in their own care. Studies like MISSION are crucial to being able to give patients the most up-to-date and useful information about their CTS treatment options.”
 
The study’s principal investigator is Dr. Victor Marwin with Bluegrass Orthopaedics in Lexington, Ky. The MISSION registry is the largest CTR study ever conducted in the United States, according to Sonex Health, with enrollment objectives targeting at least 2,000 patients at numerous investigational sites nationwide. 
 
MISSION investigators will determine whether a CTR procedure is necessary for study subjects. If so, patients will be screened to determine ifthey are eligible for enrollment. If patients qualify and consent to participate in the MISSION registry, they will receive a CTR-US procedure, and then periodically provide post-procedure follow-up information for two years.
 
“Clinical research is fundamental to Sonex Health’s mission to provide physicians with innovative therapies that reduce invasiveness, improve safety, and reduce the cost of care,” Sonex CEO Bob Paulson stated. “This formative database of clinical outcomes information about the health and long-term effectiveness of CTR-US procedures with the UltraGuideCTR device is an important element of continuing to deliver on our mission.” 
 
Real-time ultrasound guidance enables physicians to use a minimally invasive technique while performing a CTR-US procedure through a small wrist incision. Performed using only local anesthesia, CTR-US procedures with the UltraGuideCTR device are appropriate for an office-based setting, freeing up surgical suites in hospitals and ambulatory surgery centers (ASCs) for more complex procedures, and lowering the cost of care for treating CTS.
 
UltraGuideCTR is a single-use, hand-held device developed by Sonex Health’s physician co-founders—Darryl Barnes, M.D., and Jay Smith, M.D. The pair previously practiced at the Mayo Clinic and founded the Institute of Advanced Ultrasound Guided Procedures, which focuses on product innovation, clinical research, and educating physicians on honing their musculoskeletal ultrasound skills. 
 
Sonex Health develops ultrasound-guided therapies to treat common orthopedic conditions affecting the extremities, including entrapment neuropathies and tendinopathies. The company’s proprietary devices allow surgeons to use real-time ultrasound guidance to visualize critical anatomy throughout procedures. The company’s first commercial device, UltraGuideCTR is designed to treat carpal tunnel syndrome and received U.S. Food and Drug Administration clearance in 2019. The company’s second commercial device, UltraGuideTFR targets trigger finger, also known as stenosing tenosynovitis, and was released in 2022.
 
Founded in 2018 to support the Sonex Health mission and clinical excellence, the Institute of Advanced Ultrasound Guided Procedures is focused on innovation supported by clinical research and professional education and training.