Vertos Medical Inc. today announced the completion of enrollment in its nationwide, multicenter MOTION Study of its mild® Procedure. The novel prospective, randomized controlled study will collect clinically validated, patient-reported pain and function outcome measures, as well as real-world quality of life data using Fitbit activity trackers. The study enrolled approximately 150 patients who were 50-80 years of age from 19 sites across the United States and patients will be followed for two years. It is the second large, multi-center study, randomized controlled trial that has been done on the mild Procedure.
The mild procedure is a clinically proven outpatient LSS treatment that removes the cause of stenosis through a portal the size of a baby aspirin. It requires no implants, no general anesthesia, no stitches, and no overnight hospital stay.
“We are pleased that we were able to reach full enrollment so quickly and look forward to seeing the six-month results next year,” said Dr. Tim Deer, an interventional pain specialist, president and CEO of The Spine and Nerve Center of the Virginias and national principal investigator for the MOTION Study. “This study will provide high-quality data using validated pain and function outcomes measures, but we are most excited about the Fitbit activity data. This data is critical to demonstrating the real-world quality of life improvements patients experience with the mild Procedure,” added Dr. Deer.
The mild Procedure has been performed on more than 25,000 patients and its safety and efficacy have been analyzed in more than 13 clinical studies and 20 publications. Study data has shown clinically meaningful and statistically significant mobility improvement and pain reduction, with no serious procedure complications in any clinical trial.
“Vertos believes that it is critical for clinicians and patients to have access to high-quality data in order to make good clinical decisions, so we are excited that enrollment is complete for the MOTION study,” said Eric Wichems, president and CEO of Vertos Medical. “We want to thank all the physicians in our study that have actively enrolled patients.”