Assessment of Accuracy, Precision, and Feasibility of CEREBO® - a Near Infrared Light Device to detect and categorize the intracranial hematoma in patients with suspected brain injury compared to head CT scan as the gold standard:A prospective Study

This post-market surveillance study is designed to assess the diagnostic capabilities of CEREBOⓇ, a machine learning-enhanced near-infrared spectroscopy device, against the benchmark of CT scans in treating traumatic brain injury (TBI) patients. It will investigate CEREBOⓇ’s precision, sensitivity, specificity, and its overall effectiveness in identifying intracranial injuries among those suffering from TBI.The research will generate crucial insights on CEREBOⓇ’s performance and practicality in actual clinical environments, shedding light on its ability to enhance existing diagnostic approaches for TBI care. Through a direct comparison with CT scans, the recognized standard for diagnosing TBI, this study seeks to thoroughly evaluate CEREBOⓇ’s functionality and identify potential areas for enhancement, thereby promoting improved treatment outcomes for TBI patients.