Aclarion Inc. (Nasdaq: ACON, ACONW) has reported that the Texas Back Institute (TBI) will serve as a new site for the CLARITY (C hronic L ow b A ck pain R andomized I ndependent T rial stud Y) clinical trial. TBI is widely recognized for its contributions to spine technology, education and patient care.
The CLARITY trial is a randomized clinical study designed to evaluate the Nociscan solution’s ability to improve surgical outcomes for chronic low back pain. Nociscan aims to set a new standard in identifying sources of low back pain using MR Spectroscopy and Augmented Intelligence.
“Texas Back Institute has a rich tradition of excellence in research. We remain focused on the relationship between diagnostic evaluations and treatment outcomes,” said Dr. Alexander Satin, board certified orthopedic spine surgeon at Texas Back Institute. “The CLARITY trial is exciting, in part, because it builds on previously published evidence and aligns well with our patient population at Texas Back Institute. Our physicians and research leaders are pleased to participate in this important trial.”
The addition of TBI brings to five the total number of sites participating in the study, which already includes Johns Hopkins Medicine, Northwestern Medicine and Advocate Aurora Research Institute. Dr. Nicholas Theodore from Johns Hopkins Medicine serves as the principal investigator.
The CLARITY trial will enroll 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain at high-volume medical sites across the US. All participants will undergo a Nociscan prior to surgery, which will be randomized in a 1:1 ratio between surgeons who are blinded or unblinded to Nociscan results to decide on the surgical treatment (Fusion / TDR). The primary outcome measure will be the change in back pain at 12 months, assessed using a 100mm Visual Analog Scale, along with several secondary endpoints.
“The Texas Back Institute’s reputation for excellence in patient care, innovation and research is renowned,” said Ryan Bond, chief strategy officer at Broomfield-based Aclarion. “We are grateful to have this expert group of physicians and researchers participating in the CLARITY trial.”
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 platform is designed to assist physicians in distinguishing between painful and nonpainful discs in the lumbar spine through evidence-supported noninvasive methods.
