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Sonex Health Announces U.S. Clinical Study To Report Safety and Effectiveness of Office-based Carpal Tunnel Release With Ultrasound Guidance

Mar 30th, 2023

Sonex Health Announces U.S. Clinical Study To Report Safety and Effectiveness of Office-based Carpal Tunnel Release With Ultrasound Guidance

First patient was enrolled by Orthopaedic Associates in Fort Walton Beach, Fla., in multicenter prospective trial to demonstrate feasibility of carpal tunnel release using UltraGuideCTR and real-time ultrasound guidance in office-based settings

Eagan, Minn., March 30, 2023 — Sonex Health, Inc. and The Institute of Advanced Ultrasound Guided Procedures today announced enrollment of the first patient in the Multicenter Prospective Trial of Office-Based Carpal Tunnel Release with Ultrasound Guidance (ROBUST) to report the safety and effectiveness of office-based carpal tunnel release with ultrasound guidance (CTR-US) in patients with symptomatic carpal tunnel syndrome (CTS).

Dr. Victor Marwin with 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 patient in the study.

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 site of service. The ROBUST study will enroll a large cohort of subjects (n=140) suffering from symptomatic CTS, including treating patients with bilateral CTS, and follow those subjects for two years post-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,” said Dr. Ashley Pistorio. “Being able to provide my 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.

“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,” said Sonex CEO Bob Paulson. “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.”

Robust Investigators and Sites Include:

  • The study’s principal investigator: Ashley L. Pistorio, MD – University of Nevada, Las Vegas
  • David M. Megee, MD – University of Kansas Medical Center, Kansas City, Kan.
  • Paul Paterson, MD – Vero Orthopaedics, Vero Beach, Fla.
  • Victor Marwin, MD – Bluegrass Orthopaedics, Lexington, Ky.
  • James F. Watt, DO – Orthopaedic Associates, Fort Walton Beach, Fla.
  • Johnny T. Nelson, MD – The Bone & Joint Surgery Clinic, Raleigh, N.C.
  • Randall Alexander, MD – Georgia Hand, Shoulder and Elbow, Atlanta
  • Jordan Post, MD – 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. – Dr. Darryl Barnes and Dr. 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 educating physicians on how to hone their musculoskeletal ultrasound skills. UltraGuideCTR is indicated for the treatment of carpal tunnel syndrome.