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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorEMVision Medical Devices Ltd

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Brain Scan

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators