Aclarion, Inc. has announced the expansion of its multi-center Clinical Utility and Economic (CLUE) trial to New Jersey. The trial aims to assess the impact of Nociscan, Aclarion's AI-driven diagnostic tool, on treatment plans for patients suffering from chronic low back pain.
Dr. Justin Kubeck, an orthopedic spine surgeon at Ocean Pain and Spine, will be the first surgeon in New Jersey to participate in the CLUE trial. He joins Dr. John Keller in Michigan, marking the second site added since the trial's initial announcement earlier this month. The company anticipates further expansion of the trial in the coming months.
Nociscan's Role in Diagnosis
Nociscan is designed to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. The platform utilizes magnetic resonance spectroscopy (MRS) data to quantify chemical biomarkers associated with disc pain. These biomarker data are then processed through proprietary algorithms to identify potential pain sources. According to Aclarion, Nociscan provides critical insights when used in conjunction with other diagnostic tools, ultimately optimizing treatment strategies.
The CLUE Trial: Gathering Real-World Evidence
The CLUE trial is designed to evaluate how frequently Nociscan significantly impacts the decision-making process during treatment planning. Ryan Bond, Chief Strategy Officer at Aclarion, emphasized the value of real-world evidence in evaluating emerging diagnostic tools and driving payer coverage decisions. The trial seeks to provide compelling data to payers regarding Nociscan's influence on treatment decisions.
Addressing Chronic Low Back Pain
Globally, 266 million people suffer from degenerative spine disease and low back pain. Nociscan offers a noninvasive method to identify the source of pain, potentially improving treatment outcomes for this large patient population.
Surgeon's Perspective
Dr. Kubeck stated that Nociscan will be an invaluable decision support tool when evaluating diagnosis and treatment. He emphasized a procedural approach to developing the best treatment plan for each patient, considering medication, therapy, and surgery as options. Nociscan is expected to aid in this process by providing objective data to inform treatment decisions.
