Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients

Launched by EMVISION MEDICAL DEVICES LTD · May 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the EMVision emu™ Brain Scanner, which is designed to help quickly diagnose strokes, particularly those caused by bleeding in the brain (known as hemorrhagic stroke). Stroke is a serious medical issue that requires immediate attention, and while traditional imaging methods like CT or MRI scans are commonly used, they may not always be available when needed. The EMVision scanner is a portable helmet-like device that uses special radio signals to scan the head, potentially allowing for quicker diagnosis and treatment.

To participate in this trial, individuals must be at least 22 years old and present at the hospital with symptoms that suggest they may have had a stroke, within 12 hours of their symptoms starting. It's important that using the EMVision scanner does not delay their treatment. Participants will undergo standard CT or MRI scans as part of their care, along with the new scanner. However, some people may not be eligible if they have had treatment for a stroke before the scan, have certain medical devices in their head or neck, or cannot stay still during the scan. Overall, this trial aims to determine how accurate the EMVision scanner is in detecting hemorrhagic strokes, potentially leading to faster and better care for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults ≥22 years of age
• • 2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 12 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 in Emergency Department 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. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography
• • 3. Presence of any implanted electro-stimulating devices in the head and neck
• • 4. 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)
• • 5. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
• • 6. Inability to wear the investigational device (skin lesions on scalp, obvious recent blunt or penetrating injury to head, previous intracranial surgeries, neck injury etc.)
• • 7. Unable to lie still for the duration of the scan
• • 8. Pregnant or breastfeeding
• • 9. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment -