Tests a portable brain scanner for detecting bleeding in the brain
Tests a portable head scanner to detect brain bleeds in suspected stroke patients.
Plain-language title generated from the registry record
Registry title: Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Key facts
- Where
- Liverpool and Parkville, AustraliaSee the 2 sites
Where in Australia
- Liverpool HospitalLiverpool, AustraliaTaking people
- Royal Melbourne HospitalParkville, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- EMVision Medical Devices Ltd
- Trial code
- NCT06999122
- Record updated
- 27 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Adults ≥22 years of age; Observable acute neurological deficit suspected to be stroke and within 24 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 per standard of care; Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -.
Exclusion: Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis); In-patient for a neurological condition prior to suspected stroke onset; In-patient in intensive care unit prior to suspected stroke onset; 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.); Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography; Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -; Presence of any implanted electro-stimulating devices in the head and neck; Unable to lie still for the duration of the scan; Pregnant or breastfeeding.