NCT06999122Recruiting
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
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 13 May 2025
- Start date
- 26 Mar 2025
- Primary completion date
- 1 Nov 2026
- Lead sponsor
- EMVision Medical Devices Ltd
- Diseases
- Stroke
- NCT number
- NCT06999122
What you commit to
- Study type: Observational
- Planned participants: 300
- From 26 Mar 2025 to the primary completion date, 1 Nov 2026
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
- In-patient for a neurological condition prior to suspected stroke onset
- In-patient in intensive care unit prior to suspected stroke onset
- 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)
- Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
- Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
Other illness
- Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
- Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -
Other
- Presence of any implanted electro-stimulating devices in the head and neck
- Unable to lie still for the duration of the scan
- Pregnant or breastfeeding
Who the study is looking for
- Adults ≥22 years of age
- Observable acute neurological deficit suspected to be stroke and within 24 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 per standard of care
- Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liverpool Hospital Coordinator of this site? Confirm its status | Liverpool | Australia | Recruiting |
| Royal Melbourne Hospital Coordinator of this site? Confirm its status | Parkville | Australia | Recruiting |
| UTHealth Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Memorial Hermann Memorial City Medical Center Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Mayo Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| UCLA Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Mount Sinai West Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Mount Sinai Health System Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.