Study Evaluating the Accuracy of the EMVision emu Brain Scanner Helmet Device in Detecting Brain Bleeding in Adults with Suspected Stroke

What this Trial Is About

Researchers are evaluating the diagnostic accuracy of the EMVision emu22 Brain Scanner, a new portable device designed to detect intracranial hemorrhage in adults suspected of having a stroke. Stroke occurs when blood flow to the brain is blocked or when bleeding happens inside the brain, requiring quick diagnosis and treatment. This study compares the emu22 Brain Scanners results to standard imaging methods like CT and MRI to determine its ability to identify hemorrhagic stroke accurately. Participants suspected of stroke will undergo the emu22 Brain Scan using the helmet-like device that uses ultra-high frequency radio waves to scan the brain. This scan happens alongside the usual standard care imaging without delaying treatment. The study collects data on the diagnostic accuracy, safety, usability, and scan time, with the goal to demonstrate that the device can detect hemorrhage with sensitivity and specificity above 80% and complete scans in under 15 minutes. Participants will be assessed through the standard stroke diagnostic workflow, including CT or MRI scans, neurological evaluations, and a head size check to ensure device fit. The study team compares the emu22 Brain Scanner results to expert panel diagnoses blinded to the device outcome. Researchers monitor safety, usability, and device performance closely. Participation involves coordination with usual care to avoid treatment delays, and data analysis will inform the devices accuracy and potential clinical use.

Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients