Aclarion Inc. has enrolled its first two patients at the UHealth – University of Miami Health System in its pivotal CLARITY trial. This randomized study is set to evaluate the ability of Nociscan to improve surgical outcomes for patients suffering from chronic low back pain.
The CLARITY trial aims to assess the clinical and economic value of Nociscan in spine surgery by enrolling 300 patients across multiple high-volume sites in the U.S. Participants will receive a Nociscan assessment prior to undergoing surgical treatment for discogenic back pain.
Dr. Gregory Basil commented on the significance of the trial, highlighting the potential of Nociscan to enhance understanding of the sources of back pain and its relation to surgical outcomes.
The study will feature a randomized 1:1 ratio of surgeons blinded to Nociscan results and unblinded surgeons guiding the surgical treatment. The primary outcome will measure changes in back pain after 12 months, with secondary endpoints also evaluated.
Ryan Bond, chief strategy officer of Broomfield-based Aclarion, noted the importance of the trial in establishing long-term value and potential broad payer coverage for Nociscan. The trial is expected to provide essential evidence to increase access for patients dealing with chronic low back pain, an issue affecting an estimated 266 million people worldwide.