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

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.

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 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 information against the study's inclusion and exclusion criteria, as well as a head size assessment using provided gauges to confirm that their head would fit within the emu™ Brain Scanner. If the screening evaluation finds that the participant is eligible for the study then the investigator proceeds with the informed consent process. This activity occurs in parallel with the investigational site's standard practices for stroke patient management, ensuring no delay in these patients' care.

Regardless of study participation, participants will receive the complete standard of care diagnostic workflow in accordance with applicable national and international guidelines, as well as practices established at the investigational site. The standard of care diagnostic workflow is centered around acute baseline multi-modal CT imaging (and in some instances MRI). Directly following or before this imaging, and without delaying subsequent treatment, a scan is completed with the emu™ Brain Scanner to allow timely coordination between the investigational emu™ Brain Scan result and the reference standard CT/MRI imaging. If the attending physician perceives any potential risk of delaying treatment of the patient then that patient is strictly exclude from the study, entirely at the attending physician's discretion.

A central adjudicating ground truth diagnosis panel is formed of experts in the area of stroke diagnosis and reviews all diagnostic information gathered by the investigational site as per the site's standard of care diagnostic workflow. The ground truth diagnosis panel is blinded to the output from the emu™ Brain Scanner and defines the 'ground truth' or 'reference standard' diagnosis for each patient to ensure accuracy and consistency. Integral to the ground truth diagnosis panel's consideration is the assessment by the core imaging lab, who similarly review all imaging provided by the investigational sites to ensure consistent input to the ground truth expert panel.

The result of the emu™ Brain Scan is compared to the ground truth diagnosis by a biostatistician to determine the accuracy of the emu™ Brain Scanner's diagnostic output (in terms of sensitivity and specificity) with the first output evaluated being intracranial haemorrhage detection in suspected stroke patients. The biostatistician then performs all statistical analyses against the study objectives in accordance with the Statistical Analysis Plan.

Inclusion Criteria:

1. Adults ≥22 years of age
2. Observable acute neurological deficit suspected to be stroke and within 24 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 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 thrombolysis)
2. In-patient for a neurological condition prior to suspected stroke onset
3. In-patient in intensive care unit prior to suspected stroke onset
4. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
5. Presence of any implanted electro-stimulating devices in the head and neck
6. 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)
7. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
8. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
9. Unable to lie still for the duration of the scan
10. Pregnant or breastfeeding
11. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -