Aclarion, Inc. (Nasdaq: ACON, ACONW) has announced the addition of Keck Medical Center of USC as the latest site for its pivotal CLARITY trial, which aims to demonstrate the clinical and economic value of the company's Nociscan technology in spine surgery for chronic low back pain.
The CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial represents a significant advancement in the diagnosis and treatment of chronic low back pain, a condition affecting approximately 266 million people worldwide. The USC Spine Center joins other prestigious institutions participating in the trial, including Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute, and Texas Back Institute.
"Keck Medicine of USC strives to offer patients access to new treatments and procedures, and tailored treatment options for all types of spine conditions – from simple to complex," said Patrick Hsieh, MD, neurological spine surgeon with Keck Medicine of USC. "The USC Spine Center's participation in the CLARITY trial demonstrates our commitment to deepening our understanding of spinal conditions to best serve patients' specific care needs."
CLARITY Trial Design and Objectives
The CLARITY trial is a prospective, randomized multi-center study evaluating patients scheduled for surgical treatment of 1- or 2-level discogenic low back pain. The study will enroll 300 patients across multiple high-volume sites throughout the United States. All participants will undergo Nociscan evaluation prior to surgery.
The trial employs a 1:1 randomization ratio, with surgeons either blinded or unblinded to Nociscan results when determining surgical treatment approaches (Fusion/Total Disc Replacement). The primary endpoint is the change in back pain as measured on a 100mm Visual Analog Scale (VAS) at 12 months compared to baseline, with several secondary endpoints also being collected.
Dr. Nicholas Theodore of Johns Hopkins Medicine serves as the principal investigator for this landmark study.
Nociscan Technology: A Novel Approach to Pain Identification
Aclarion's Nociscan is the first evidence-supported SaaS platform designed to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The technology leverages Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms.
Through a cloud connection, Nociscan receives MRS data from an MRI machine for each lumbar disc being evaluated. Proprietary signal processing techniques then extract and quantify chemical biomarkers demonstrated to be associated with disc pain. This biomarker data is entered into algorithms to indicate if a disc may be a source of pain, providing physicians with critical insights to optimize treatment strategies.
"The USC Spine Center has a long history of being at the forefront of innovation and research to advance patient care and we look forward to partnering with Dr. Hsieh and the USC Spine Center team on the CLARITY trial," said Ryan Bond, Chief Strategy Officer at Aclarion. "We anticipate the CLARITY trial to represent a turning point in how physicians are able to leverage Nociscan to understand and diagnose chronic low back pain for the millions of patients suffering from this debilitating condition."
Addressing a Global Healthcare Challenge
Chronic low back pain represents one of the most significant healthcare challenges globally. Current diagnostic methods often struggle to precisely identify the source of pain, leading to suboptimal treatment outcomes and unnecessary procedures.
By objectively quantifying chemical biomarkers associated with disc pain, Nociscan aims to transform the diagnostic landscape for chronic low back pain. The technology has the potential to significantly improve surgical outcomes by ensuring interventions target the actual source of pain.
If successful, the CLARITY trial could establish Nociscan as the new gold standard for identifying sources of low back pain, potentially benefiting millions of patients worldwide who suffer from this debilitating condition.
Expanding Clinical Evidence
The addition of USC Spine Center to the CLARITY trial further strengthens the study's credibility and reach. Known for treating complex spine conditions with cutting-edge technologies, USC's participation underscores the potential significance of Nociscan in advancing spine care.
As the trial progresses, Aclarion continues to build clinical evidence supporting Nociscan's utility in improving diagnostic accuracy and treatment outcomes for chronic low back pain. The company's innovative approach combines advanced imaging technology with artificial intelligence to address a critical unmet need in spine care.
The results of the CLARITY trial could potentially reshape how chronic low back pain is diagnosed and treated, offering new hope to patients and physicians alike in managing this challenging condition.
