Actively Recruiting
Multi-Center, Prospective, Paired Diagnosis Study of the EMVision emu Brain Scanner for Detecting Intracranial Hemorrhage in Suspected Stroke Patients
Led by EMVision Medical Devices Ltd · Updated on 2025-06-13
300
Participants Needed
4
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the EMVision emu™ Brain Scanner, a new portable device designed to diagnose stroke, particularly intracranial hemorrhage, by using ultra-high frequency radio signals. Stroke occurs when blood flow in the brain is blocked or when bleeding happens inside the brain, and quick diagnosis is critical. This study aims to determine how accurately the emu™ Brain Scanner detects hemorrhagic stroke compared to standard imaging methods like CT or MRI. The study involves adults suspected of having a stroke who arrive at emergency departments. Participants will undergo a standard CT or MRI scan, and around the same time, they will be scanned with the emu™ Brain Scanner device, which fits like a helmet on the head. The study compares the emu™ Brain Scanner results to the expert-reviewed standard imaging to see if it can reliably detect hemorrhages without delaying treatment. The device scan is expected to take less than 15 minutes. Participants will receive all usual care without delay. Researchers will collect diagnostic data, including the emu™ Brain Scanner scan, CT/MRI results, and clinical information, which an expert panel will review to establish the true diagnosis. The main outcome is the device's sensitivity and specificity in detecting hemorrhagic stroke within 30 minutes of the standard scan. Safety, usability, and any device issues will also be assessed throughout the study, which runs until late 2026.
CONDITIONS
Brief 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 to hospital 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 as part of 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 EMVision emu Brain Scanner scan
- Contraindications to neuroimaging such as contrast allergy or 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/tissue (excluding distant objects like dental implants)
- Presence of intracranial pressure monitor or similar sensor affecting device placement
- Inability to wear the investigational device due to skin lesions, recent head injury, prior brain surgery, or neck injury
- Unable to lie still for the scan duration
- Pregnant or breastfeeding
- Any other condition or symptoms preventing study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 hours from symptom onset to scanning
Participants undergo the EMVision emu™ Brain Scanner scan in addition to standard CT or MRI brain imaging to detect intracranial hemorrhage without delaying treatment.
1 visit (in-person)
Duration - Up to study completion in November 2026
Participants' diagnostic results are reviewed by an expert panel to establish a ground truth diagnosis, with statistical analysis performed to evaluate the accuracy of the EMVision emu™ Brain Scanner.
No additional visits required for participants
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
S
Sadie Burnham
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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