RecruitingNCT06999122

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

Multi-Center, Prospective, Consecutive, Paired Diagnosis, Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

Sponsor

EMVision Medical Devices Ltd

Enrollment

300 participants

Start Date

Mar 26, 2025

Study Type

OBSERVATIONAL

Conditions

Stroke Hemorrhagic Stroke

Summary

The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available. EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Brain Scan for people with hemorrhagic stroke and stroke. The study is currently recruiting participants at 4 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBrain Scan

The EMVision emu™ Brain Scanner is a device system which scans the human brain using radiofrequency techniques. The emu™ headset is placed on the head of a patient, enabling ultra-high frequency radio wave (also commonly referred to as microwave) signal propagation into the patient's head. The radio-waves reflect from and transmit through the tissue boundaries and are detected by the receiver antennae within the headset. The transceivers operate at very low-level signals in accordance with national and international safety thresholds. The scattered signals carry information on the scanned tissues.