Status:
RECRUITING
Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Lead Sponsor:
EMVision Medical Devices Ltd
Conditions:
Stroke
Hemorrhagic Stroke
Eligibility:
All Genders
22+ years
Brief 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 ...
Detailed 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 p...
Eligibility Criteria
Inclusion
- Adults ≥22 years of age
- Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 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 in Emergency Department per standard of care
- Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner -
Exclusion
- Has received treatment for current (suspected) stroke event prior to initial CT/MRI scan OR EMVision emu™ Brain Scanner scan (such as thrombolysis)
- Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
- Presence of any implanted electro-stimulating devices in the head and neck
- 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.)
- Unable to lie still for the duration of the scan
- Pregnant or breastfeeding
- Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -
Key Trial Info
Start Date :
March 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 28 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06999122
Start Date
March 26 2025
End Date
November 28 2026
Last Update
June 13 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Jacksonville
Jacksonville, Florida, United States, 32224
2
UTHealth
Houston, Texas, United States, 77030
3
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
4
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050