Actively Recruiting
Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Led by EMVision Medical Devices Ltd · Updated on 2025-06-13
300
Participants Needed
4
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 22 years of age or older
- Presenting with acute neurological deficit suspected to be stroke within 12 hours of symptom onset
- Use of the EMVision emu™ Brain Scanner will not delay patient treatment
- Undergoing CT or MRI brain imaging after clinical evaluation in the Emergency Department as standard care
- Head size suitable for scanning with the EMVision emu™ Brain Scanner
You will not qualify if you...
- Received treatment for current suspected stroke before initial CT/MRI or emu™ Brain Scanner scan (e.g., thrombolysis)
- Contraindications to neuroimaging such as contrast allergy or other conditions preventing CT, MRI, or angiography
- Presence of implanted electro-stimulating devices in head or neck
- Presence of metallic implants in cranial vault or surrounding bones/tissues (excluding dental implants or nasal piercings)
- Presence of intracranial pressure monitor or similar sensors interfering with device placement
- Inability to wear the investigational device due to scalp skin lesions, recent head injury, prior brain surgeries, or neck injury
- Unable to lie still for the duration of the scan
- Pregnant or breastfeeding
- Any other condition or symptoms preventing study participation per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Mayo Jacksonville
Jacksonville, Florida, United States, 32224
Not Yet Recruiting
2
UTHealth
Houston, Texas, United States, 77030
Not Yet Recruiting
3
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Not Yet Recruiting
4
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Actively Recruiting
Research Team
C
Christian Wight, PhD
CONTACT
S
Sadie Burnham
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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