UHealth — University of Miami Health System and the University of Miami Miller School of Medicine provide world-class research and renowned clinical expertise in spine surgery
Aclarion, Inc., a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, announced the addition of UHealth — University of Miami Health System and the University of Miami Miler School of Medicine as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The landmark CLARITY study is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
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“I have a particular interest in ‘ultra-minimally’ invasive approaches to the spine including endoscopic spine surgery,” said Gregory Basil, MD, of UHealth who is also Director of Endoscopic Spine Surgery and Assistant Professor at the University of Miami Miller School of Medicine, University of Miami. “We believe in customizing treatments to each patient’s pathology, goals, needs, and lifestyle, and in this regard, leveraging novel technologies, like Nociscan, to better understand our patient’s low back pain for personalized treatments. The CLARITY trial is a unique opportunity for me and my colleagues at the Miller School of Medicine to advance the spine industry and showcase the research capabilities at the University of Miami.”
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UHealth in conjunction with the Miller School of Medicine, is the latest CLARITY trial site, joining Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute, Texas Back Institute, and Keck Medicine at USC. 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 (Fusion / TDR). 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.
Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. Aclarion’s Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes.
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Source – GlobeNewswire
