First Patient Enrolls in Sonex Health’s U.S. Clinical Study to Treat Carpal Tunnel Syndrome

Sonex Health and The Institute of Advanced Ultrasound Guided Procedures have announced enrollment of the first patient in the Trial of Ultrasound Guided Carpal Tunnel Release (CTR) Versus Traditional Open Release (TUTOR)—the first multicenter randomized controlled trial in the U.S. to compare the efficacy and safety of traditional mini-open carpal tunnel release (mOCTR) and carpal tunnel release using the FDA-cleared UltraGuideCTR and real-time ultrasound guidance.
 
Dr. James F. Watt, an orthopedic hand surgeon with Orthopaedic Associates in Destin, Fla. enrolled the first patient in the post-market TUTOR study.
 
“I am honored to be an investigator in the TUTOR study and provide UltraGuideCTR and real-time ultrasound guidance as a safe and proven option to treat my patients suffering from debilitating carpal tunnel syndrome,” said Dr. Watt. “I believe this technique is the biggest game changer in how carpal tunnel will be treated. I look forward to using this minimally invasive approach to help patients recover faster and return to enjoying the activities they couldn’t do prior to being treated.”
 
“Both surgeons and patients prefer the smallest incisions possible so patients can quickly get back to doing the things they love,” said Dr. Kyle R. Eberlin, associate professor of surgery at Harvard Medical School, a plastic and reconstructive surgeon at Massachusetts General Hospital and the study’s principal investigator. “The TUTOR study gives the investigators the opportunity to undertake a disciplined comparative assessment of an approach to treat CTS that requires only a very small incision while using ultrasound guidance to maintain visualization of the anatomy throughout the procedure.”

Making mOTCR Procedures Less Invasive

Traditional mOCTR procedures are performed by making an incision in the base of the palm and then dividing the transverse carpal ligament to relieve pressure on the median nerve to treat the pain and discomfort of carpal tunnel syndrome (CTS). Real-time ultrasound guidance enables physicians to use a minimally invasive technique while performing CTR through a small wrist incision (rather than a palmar incision), enabling most patients to resume normal activities within days versus weeks or months often experienced following mOCTR surgeries.
  
UltraGuideCTR is a single-use, hand-held device developed by the physician co-founders of Sonex Health – 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.