Aclarion Expands CLARITY Trial Network with NYU Langone Health
Event summary
- NYU Langone Health joins Aclarion's CLARITY trial network, bringing the total number of enrollment sites to eleven.
- The CLARITY trial is a 300-patient, prospective, randomized, multi-center study evaluating Nociscan for chronic low back pain.
- NYU Langone Spine Center performs over 4,700 spine procedures annually and serves more than 25,000 patients.
- Nociscan aims to improve surgical outcomes for chronic low back pain using MR Spectroscopy (MRS) and Augmented Intelligence (AI).
- The primary endpoint of the CLARITY trial is the change in back pain measured on a 100mm VAS Back at 12 months compared to baseline.
The big picture
Aclarion's expansion of the CLARITY trial network to include NYU Langone Health underscores the growing interest in validating Nociscan's clinical and economic value. This move aligns with the broader trend of leveraging AI and advanced diagnostics to improve surgical outcomes in chronic pain management. The inclusion of high-volume spine centers suggests a strategic push to gather robust evidence that could position Nociscan as a standard tool in spine surgery.
What we're watching
- Trial Momentum
- The pace at which Aclarion can enroll patients across the eleven sites will determine the timeline for CLARITY trial results.
- Clinical Validation
- Whether Nociscan can demonstrate a significant improvement in surgical outcomes for chronic low back pain.
- Market Adoption
- How the inclusion of prestigious institutions like NYU Langone Health will influence the broader adoption of Nociscan in clinical practice.