Aclarion Inc. (Nasdaq: ACON, ACONW), a Broomfield health care technology company, has reported that Advocate Aurora Research Institute, part of Advocate Health, will participate as a site in the CLARITY (Chronic Low Back pain Randomized Independent Trial studY) trial. The trial aims to demonstrate the clinical and economic value of Nociscan in spine surgery.
“Advocate Aurora Research Institute conducts hundreds of unique research projects each year to advance healthcare worldwide,” said Dr. Patrick Sugrue, neurosurgeon at Advocate Health. “From groundbreaking clinical trials to academic and biorepository research – we’re translating the latest findings into better care, prevention strategies and treatments for patients and their families.” He added that Aclarion’s Nociscan platform serves as an advanced diagnostic tool for evaluating low back pain.
The CLARITY trial will be a prospective, randomized multi-center study involving 300 patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain across multiple high-volume sites in the U.S. All participants will receive a Nociscan before surgery. The trial will randomize patients in a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to direct the surgical treatment.
The primary endpoint is the change in back pain, measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints planned. Dr. Nicholas Theodore from Johns Hopkins Medicine is the principal investigator for the trial.
“Millions of people worldwide suffer from chronic low back pain yet identifying the source of pain is not clearcut with traditional imaging. Nociscan aims to change that by enabling physicians to ‘see’ the difference between painful and non-painful discs so they can create more precise treatment plans,” said Ryan Bond, chief strategy officer at Aclarion. “We are honored to work with Dr. Sugrue and Advocate Health on the CLARITY trial to demonstrate the clinical value of Nociscan.”
Chronic low back pain affects approximately 266 million people globally, presenting a significant healthcare challenge. Aclarion’s Nociscan is a SaaS platform designed to assist physicians in distinguishing between painful and non-painful discs in the lumbar spine, potentially leading to better surgical outcomes.
