Sonex Health Announces First Patient Enrolled in MISSION Clinical Registry to Collect Real-World Data on Patients Treated with Carpal Tunnel Release Using Ultrasound Guidance
First patient enrolled by North Texas Hand Center in landmark US multi-center clinical study
Eagan, Minn., March 6, 2024 — Sonex Health, Inc. and The Institute of Advanced Ultrasound Guided Procedures today announced enrollment of the first patient in the Post-Market RegIStry of the Patient Experience when uSing UltraGuIdeCTR fOr Carpal TuNnel Release (MISSION) registry. Dr. Stuart Hilliard, with North Texas Hand Center, was the first investigator to enroll a patient into the study.
MISSION is designed to be the largest multi-center clinical study in the United States assessing the treatment of patients suffering from carpal tunnel syndrome. This landmark study will collect real-world, long-term data on patients suffering from carpal tunnel syndrome (CTS) who are treated with a carpal tunnel release (CTR) procedure using Sonex Health’s commercially available device, UltraGuideCTR™ using real-time ultrasound guidance (CTR-US).
“Participating in this important study is in direct alignment with how I practice medicine,” said Dr. Hilliard. “I firmly 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 U.S., with enrollment objectives targeting at least 2,000 patients at numerous investigational sites across the country.
For patients suffering from CTS, the MISSION investigators will determine if a CTR procedure is indicated, and if so, the patients will be screened to determine if they 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 over a period of 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,” said Sonex CEO Bob Paulson. “This formative database of valuable 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 the physician co-founders of Sonex Health, Inc. – Dr. Darryl Barnes and Dr. Jay Smith. Drs. Barnes and Smith 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 educating physicians on how to hone their musculoskeletal ultrasound skills. UltraGuideCTR is indicated for the treatment of carpal tunnel syndrome.
For more information about the MISSION clinical registry, visit: www.ctrstudy.com. Physicians interested in participating as investigators in this study can visit www.sonexhealth.com or reach out to info@sonexhealth.com.
About Sonex Health
Sonex Health, Inc. 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™, was designed to treat carpal tunnel syndrome and received FDA clearance in 2019. The company’s second commercial device, UltraGuideTFR™ was designed to treat trigger finger, also known as stenosing tenosynovitis, and was released in 2022.
For information about Sonex Health, UltraGuideCTR, and UltraGuideTFR visit www.sonexhealth.com.
About the Institute of Advanced Ultrasound Guided Procedures
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 robust clinical research and world-class professional education and training that transforms the treatment experience for patients, providers, and payers. For more information about the Institute visit www.sonexhealth.com/educational-institute.