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RECRUITING
NCT06999122

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

Sponsor: EMVision Medical Devices Ltd

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

22 Years - Any

Study Type

OBSERVATIONAL

Enrollment

300

Start Date

2025-03-26

Completion Date

2026-11-28

Last Updated

2025-06-13

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Brain 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.

Locations (4)

Mayo Jacksonville

Jacksonville, Florida, United States

UTHealth

Houston, Texas, United States

Liverpool Hospital

Liverpool, New South Wales, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia