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

NCT06999122 | Recruiting DMC FDA Device

• 1 other identifier: EMV-CIP-03
• Study Type: observational
• Target: 300
• Locations: 2 countries
• Sites: 4

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 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

Stroke; Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• Demonstrate haemorrhage detection sensitivity >80% and specificity >80%

  <30 minutes from acute baseline CT/MRI

Secondary Outcomes (4)

• Demonstrate the time to complete an emu™ Brain Scan is <15 minutes

  <30 minutes from acute baseline CT/MRI

• Evaluate safety of the device

  <30 minutes from acute baseline CT/MRI

• Evaluate usability of the device

  <30 minutes from acute baseline CT/MRI

• Evaluate device deficiencies

  <30 minutes from acute baseline CT/MRI

Study Arms (2)

Intracranial Haemorrhage Group A

Diagnostic Test: Brain Scan

Other Group B

Group B includes all patients enrolled in the study ultimately diagnosed with a condition other than intracranial haemorrhage, including ischaemic stroke, transient ischaemic attack, or any of a variety of stroke mimicking conditions.

Diagnostic Test: Brain Scan

Interventions

Brain Scan DIAGNOSTIC_TEST

The EMVision emu™ Brain Scanner is a device system which scans the human brain using radiofrequency techniques. The emu™ headset is placed on the head of a patient, enabling ultra-high frequency radio wave (also commonly referred to as microwave) signal propagation into the patient's head. The radio-waves reflect from and transmit through the tissue boundaries and are detected by the receiver antennae within the headset. The transceivers operate at very low-level signals in accordance with national and international safety thresholds. The scattered signals carry information on the scanned tissues.

Intracranial Haemorrhage Group A; Other Group B

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

300 subjects across two study arms

You may qualify if:

• 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 -

You may not qualify if:

• 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 -

Sponsors & Collaborators

• EMVision Medical Devices Ltd: lead

Study Sites (4)

Mayo Jacksonville

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

UTHealth

Houston, Texas, 77030, United States

NOT YET RECRUITING

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

NOT YET RECRUITING

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

RECRUITING

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Reade De Leacy, MBBS(Hons) FRANZCR

  Associate Professor of Neurosurgery and Radiology Director of Neurointerventional Spine Site Director Cerebrovascular Services Mount Sinai Queens Co-director Neuroendovascular Surgery Fellowship Department of Neurosurgery Mount Sinai Health System

  PRINCIPAL INVESTIGATOR

• Angela Dos Santos, PhD

  Melbourne Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Wight, PhD

CONTACT

61 (0) 490 109 797; cwight@emvision.com.au

Sadie Burnham

CONTACT

7742078910; sburnham@vastrax.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 31, 2025
• Study Start: March 26, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 28, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (2)