Aclarion announces Texas Back Insitute as new CLARITY trial site

Aclarion (ACON) announced the addition of the Texas Back Institute as a CLARITY trial site. The pivotal CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery. Texas Back Institute joins the growing roster of previously announced CLARITY trial sites, which includes Johns Hopkins Medicine, Northwestern Medicine and Advocate Aurora Research Institute. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine. The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment. The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected.