Aclarion announces first enrollment at pivotal CLARITY trial

Aclarion (ACON) announced that the UHealth – University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY – Chronic Low bAck pain Randomized Independent Trial studY – trial. The pivotal CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery. The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment for discogenic back pain in up to two lumbar levels. 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 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. Other enrolling sites include Northwestern Medicine, Advocate Health, Texas Back Institute, and USC.