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

Inclusion Criteria5

Adults ≥22 years of age
Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 hours of symptom onset
The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient
CT or MRI brain imaging following clinical evaluation in Emergency Department per standard of care
Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -

Exclusion Criteria9

Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
Presence of any implanted electro-stimulating devices in the head and neck
Presence of any metallic implants in the cranial vault or surrounding bones/tissue (Note that metallic objects distant from the scan area, such as dental implants, nasal piercing etc., are acceptable)
Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
Unable to lie still for the duration of the scan
Pregnant or breastfeeding
Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -

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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.