Sonex Health Begins Study of Carpal Tunnel Release With Ultrasound Guidance

Sonex Health Inc. and The Institute of Advanced Ultrasound Guided Procedures today have enrolled the first patient in a multicenter prospective clinical trial of Office-Based Carpal Tunnel Release with Ultrasound Guidance (ROBUST). The study aims to measure the safety and efficacy of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).

“We are very grateful for the interest and commitment of the ROBUST investigators and their staff for the time and effort they are dedicating to advance patient care as part of this study,” Sonex CEO Bob Paulson said. “The experience and expertise of the ROBUST investigators are critical to evaluating the clinical benefits of using UltraGuideCTR and real-time ultrasound guidance to treat the painful and debilitating effects of carpal tunnel syndrome, as well as the health economic benefits of moving CTR procedures to a lower cost site of care that benefits both patients and providers.”
 
Dr. Victor Marwin of Bluegrass Orthopaedics in Lexington, Ky., was the first investigator to consent a patient into the study, and Dr. James F. Watt with Orthopaedic Associates in Fort Walton Beach, Fla., was the first to enroll and treat a study patient.
 
The purpose of this multicenter trial is to demonstrate real-world clinical evidence of the safety and efficacy of CTR-US performed exclusively in an office procedure room. The ROBUST study will enroll a large subject cohort (n=140) suffering from symptomatic CTS, including treating patients with bilateral CTS, and follow those subjects for two years after treatment.
 
“I’m pleased to be participating in this important research to evaluate the safety and effectiveness of performing CTR-US in an office-based setting,” principal study investigator Ashley Pistorio, M.D., said. “Being able to provide patients with this minimally invasive technique in my office, using only local anesthesia, would be a game changer in reducing healthcare costs and improving the patient experience. The opportunity to treat patients suffering from bilateral CTS in a single procedure eliminates the need for patients to schedule two separate procedures and undergo recovery following each procedure when both wrists need to be treated.”
 
Typically, CTR procedures have been performed in a hospital or an ambulatory surgery center (ASC). However, with the continuing advancements in technology, increased demand from both patients and providers, and concerns about growing healthcare costs, there is a distinct trend to move CTR procedures from surgical suites into office-based sites of service.  
 
ROBUST investigators and sites include:

• Ashley L. Pistorio, University of Nevada, Las Vegas
• David M. Megee, M.D.,University of Kansas Medical Center, Kansas City, Kan.
• Paul Paterson, M.D., Vero Orthopaedics, Vero Beach, Fla.
• Victor Marwin, M.D., Bluegrass Orthopaedics, Lexington, Ky.
• James F. Watt, D.O., Orthopaedic Associates, Fort Walton Beach, Fla.
• Johnny T. Nelson, M.D., The Bone & Joint Surgery Clinic, Raleigh, N.C.
• Randall Alexander, M.D., Georgia Hand, Shoulder and Elbow, Atlanta
• Jordan Post, M.D., New Braunfels Orthopaedic Surgery and Sports Medicine, New Braunfels, Texas

Real-time ultrasound guidance enables physicians to use a minimally invasive technique while performing CTR through a small wrist incision. Performed under local anesthesia, CTR-US is appropriate for an office-based setting, freeing up hospitals and ASCs for more complex procedures, and lowering the cost of care for treating CTS.
 
UltraGuideCTR is a single-use, hand-held device developed by the physician co-founders of Sonex Health Inc.—Drs. Darryl Barnes and Jay Smith—both of whom previously practiced at the Mayo Clinic in Rochester, Minn., and founded the Institute of Advanced Ultrasound Guided Procedures, which focuses on product innovation, clinical research, and education on ways physicians can hone their musculoskeletal ultrasound skills. UltraGuideCTR is indicated for the treatment of carpal tunnel syndrome.
 
Sonex Health is a leader in innovative 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, thereby reducing both invasiveness and the cost of care, and enabling patients to return to their normal activities sooner. 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, treats 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 that transforms the treatment experience for patients, providers, and payers.