UHealth-University of Miami Health System has enrolled the first two patients in Aclarion's pivotal CLARITY trial, marking a significant milestone for the healthcare technology company's efforts to revolutionize chronic low back pain diagnosis and treatment. The randomized study aims to demonstrate whether Nociscan technology can improve surgical outcomes by using MR spectroscopy and augmented intelligence algorithms to identify the precise sources of spinal pain.
Trial Design and Objectives
The CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) is a prospective, randomized multi-center study designed to evaluate patients scheduled for surgical treatment of discogenic back pain in up to two lumbar levels. The study will enroll 300 patients across multiple high-volume sites throughout the United States, with all participants receiving a Nociscan prior to surgery.
The trial employs a 1:1 randomization ratio, comparing surgeons who are blinded to Nociscan results versus those who have access to the technology to guide their surgical treatment decisions between fusion and total disc replacement (TDR). The primary endpoint measures change in back pain using a 100mm Visual Analog Scale (VAS) at 12 months compared to baseline, with several secondary endpoints also being collected.
Clinical Leadership and Participating Institutions
Dr. Nicholas Theodore of Johns Hopkins Medicine serves as the principal investigator for the trial. At the University of Miami, Dr. Gregory Basil, Director of Endoscopic Spine Surgery and Assistant Professor at UHealth and the Miller School of Medicine, expressed enthusiasm about the study's potential impact.
"CLARITY is an important trial for spine surgeons and their patients with low back pain," Dr. Basil commented. "The additional information provided by Nociscan is challenging pre-conceived notions about the sources of low back pain and we look forward to understanding the correlation between surgical outcomes and the patient-specific biomarkers provided in the unblinded cohort."
The multi-center trial includes several prestigious medical institutions: Johns Hopkins Medicine in Baltimore, Northwestern Medicine in Chicago, Advocate Health in Charlotte, North Carolina, Texas Back Institute in Plano, and the University of Southern California in Los Angeles.
Technology and Market Implications
Nociscan represents Aclarion's proprietary approach to addressing chronic low back pain through biomarkers and augmented intelligence algorithms. The technology uses MR spectroscopy combined with AI to help physicians identify the specific location of chronic low back pain, potentially becoming what the company describes as "the gold standard" for identifying sources of low back pain.
Ryan Bond, Chief Strategy Officer of Aclarion, emphasized the trial's strategic importance: "The CLARITY trial is a major catalyst for driving long-term value as we believe these results will be an important milestone in securing broad payer coverage for Nociscan. Our timelines for the CLARITY trial remain on track due to the commitment of our trial investigators and their teams to help us generate the evidence needed to advance Nociscan and expand access to patients in need."
Timeline and Expected Outcomes
The company maintains that enrollment remains on track, with internal interim results expected in the second quarter of 2026. The trial's success could significantly impact the treatment landscape for chronic low back pain by providing surgeons with more precise diagnostic information to guide their surgical decisions, potentially improving patient outcomes and reducing healthcare costs associated with ineffective procedures.
