Aclarion Inc. (Nasdaq: ACON, ACONW) has reported that the Keck Medical Center of USC has joined the CLARITY (Chronic Low Back Pain Randomized Independent Trial Study) as a trial site. The USC Spine Center specializes in treating complex spine conditions using advanced technologies.
The CLARITY trial is a randomized clinical study aimed at demonstrating the clinical and economic value of Nociscan in spine surgery for chronic low back pain. “Keck Medicine of USC strives to offer patients access to new treatments and procedures, and tailored treatment options for all types of spine conditions – from simple to complex,” said Dr. Patrick Hsieh, a neurological spine surgeon with Keck Medicine of USC. “The USC Spine Center’s participation in the CLARITY trial demonstrates our commitment to deepening our understanding of spinal conditions to best serve patients’ specific care needs.”
Keck Medical Center joins other notable institutions in the trial, including Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute and Texas Back Institute. The trial is led by principal investigator Dr. Nicholas Theodore of Johns Hopkins Medicine.
The CLARITY trial will evaluate 300 patients scheduled for surgical treatment of 1- or 2- level discogenic low back pain across several high-volume sites in the U.S. Participants will undergo Nociscan examination prior to surgery, with a randomized allocation of surgeons either blinded or unblinded to the Nociscan results. The primary endpoint is the change in back pain assessed on a 100mm VAS at 12 months compared to baseline.
“The USC Spine Center has a long history of being at the forefront of innovation and research to advance patient care and we look forward to partnering with Dr. Hsieh and the USC Spine Center team on the CLARITY trial,” said Ryan Bond, chief strategy officer at Broomfield-based Aclarion. “We anticipate the CLARITY trial to represent a turning point in how physicians are able to leverage Nociscan to understand and diagnose chronic low back pain for the millions of patients suffering from this debilitating condition.”
Chronic low back pain is a significant global health issue, affecting approximately 266 million people worldwide with degenerative spine disease and low back pain. Aclarion’s Nociscan is the first evidence-supported software solution to help physicians noninvasively determine the presence of painful versus nonpainful discs in the lumbar spine, potentially improving surgical outcomes.
