Aclarion Inc. (Nasdaq: ACON, ACONW), a Broomfield health care technology company, has named Northwestern Medicine as the initial site for its CLARITY trial. This study is aimed at demonstrating the clinical and economic value of Nociscan in spine surgery, particularly for chronic low back pain.
The CLARITY trial is a randomized study designed to show Nociscan’s ability to improve surgical outcomes while reducing costs. “Northwestern Medicine is a leader in clinical trials. In 2024, Northwestern led over 6,900 clinical studies with 372,561 study participants,” said Dr. Alpesh Patel, professor and co-director of the Northwestern Center for Spine Health. “We are pleased to participate in Aclarion’s CLARITY trial, a groundbreaking randomized controlled trial examining Nociscan’s impact on discogenic low back pain surgical outcomes. Low back pain is a complex problem and advancements like Nociscan are helping to advance our understanding of low back pain in fundamentally important ways.”
The CLARITY trial, which is fully funded, will be led by Dr. Nicholas Theodore of Johns Hopkins as the principal investigator. This prospective, randomized multi-center study will evaluate patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain, enrolling 300 subjects across multiple high-volume sites in the U.S. All patients will receive Nociscan prior to their surgery.
The study will implement a 1:1 randomization ratio of surgeons who are blinded or unblinded to Nociscan to guide treatment decisions, focusing on either Fusion or TDR procedures. The primary endpoint is the change in back pain measured on a 100mm Visual Analog Scale (VAS) at 12 months compared to baseline, along with several secondary endpoints.
Aclarion aims to position Nociscan as the gold standard for identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence (AI). Chronic low back pain affects approximately 266 million people worldwide.
