Aclarion Inc. enrolled the first patient in its CLARITY trial, aimed at assessing the impact of its Nociscan technology on surgical treatments for chronic low back pain. The initial participant was enrolled at the Texas Back Institute, recognized for its advancements in spine care.
The CLARITY trial is a randomized clinical study designed to evaluate the effectiveness of Nociscan, which aims to improve surgical outcomes for patients suffering from chronic low back pain. The study will include a total of 300 patients across multiple high-volume medical centers in the U.S. All participants will undergo a Nociscan evaluation prior to their surgery.
Dr. Alexander Satin, the principal investigator at the Texas Back Institute, said, “The CLARITY trial will allow us to observe patient-specific critical pain biomarker data and the relationship with surgical outcomes.” The study will analyze changes in back pain after 12 months of surgery, along with several secondary outcomes.
The Nociscan technology is designed to help physicians accurately identify the sources of low back pain, distinguishing between painful and non-painful discs in the lumbar spine. This approach is positioned to enhance surgical results for the millions affected by degenerative spine disease globally.
Broomfield-based Aclarion expects to obtain interim results from the trial by the second quarter of 2026.