Aclarion Inc. (Nasdaq: ACON, ACONW), a Broomfield health care technology firm, has announced the launch of the multi-center Clinical Utility and Economic (CLUE) Trial. The trial aims to quantify the frequency with which surgeons alter their original treatment plans after receiving data from Aclarion’s proprietary Nociscan technology.
In the CLUE Trial, surgeons will determine their surgical treatment plans prior to viewing Nociscan data and will then report any changes made to those plans after reviewing the data. Multiple physicians and sites are expected to enroll in CLUE in the coming months, contributing practical real-world data to Aclarion’s growing repository of clinical evidence.
“Diagnosing the source of chronic low back pain is a significant challenge for clinicians and often results in the omission or inclusion of treatment on discs that do not correlate to improved clinical outcomes,” said Ryan Bond, chief strategy officer of Aclarion. “Evidence points to a significant improvement in outcomes when Nociscan information is added to the treatment planning process. CLUE is specifically designed to quickly determine how influential Nociscan is in evaluating which discs a physician decides to treat.”
Earlier this year, Aclarion launched the CLARITY trial to demonstrate improved surgical outcomes when Nociscan data is included in the decision-making process. CLARITY is a multicenter, prospective randomized trial, while CLUE aims to provide immediate insights into the likelihood of CLARITY’s success by evaluating how often Nociscan data influences treatment decisions.
“CLUE represents an opportunity to study the use of Nociscan in an independent and scalable fashion,” said Brent Ness, CEO of Aclarion. “Any physician with access to Nociscan can easily access this survey tool to build their own evidence and body of data to use when advocating for insurance coverage of Nociscan.”
Aclarion uses Magnetic Resonance Spectroscopy (MRS), proprietary signal processing techniques, biomarkers and augmented intelligence algorithms to enhance clinical treatments. The company’s initial focus is on chronic low back pain, with Nociscan serving as its first MRS-based, evidence-supported SaaS platform designed to noninvasively help physicians identify painful and nonpainful discs in the lumbar spine.