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
EMVision Medical Devices Ltd
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.
Description
This clinical investigation is a paired diagnosis, diagnostic performance study intended to quantify the accuracy of the emu™ Brain Scanner's diagnostic output in comparison to current gold-standard practices including multi-modal neuroimaging by CT and/or MRI. Any adult with neurological deficit suspected to be stroke presenting to the investigational site's emergency department shall be considered as potentially eligible for the study. Potential participant's eligibility for the study is determined via screening evaluation which includes a review of available demographic and medical history…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults ≥22 years of age 2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 hours of symptom onset 3. The use of the EMVision emu™ Brain Scanner will not delay the treatment of the patient 4. CT or MRI brain imaging following clinical evaluation in Emergency Department per standard of care 5. Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner - Exclusion Criteria: 1. Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as th…
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.
Locations (4)
- Mayo JacksonvilleJacksonville, Florida
- UTHealthHouston, Texas
- Liverpool HospitalLiverpool, New South Wales
- Royal Melbourne HospitalParkville, Victoria