Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06999122




Registration number
NCT06999122
Ethics application status
Date submitted
13/05/2025
Date registered
31/05/2025
Date last updated
13/06/2025

Titles & IDs
Public title
Diagnostic Performance Study of the EMVision Emu™ Brain Scanner in the Detection of Intracranial Hemorrhage in Suspected Stroke Patients
Scientific title
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
Secondary ID [1] 0 0
EMV-CIP-03
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Hemorrhagic Stroke 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - Brain Scan

Intracranial Haemorrhage Group A -

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.


Diagnosis / Prognosis: Brain Scan
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.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Demonstrate haemorrhage detection sensitivity >80% and specificity >80%
Assessment method [1] 0 0
Timepoint [1] 0 0
<30 minutes from acute baseline CT/MRI
Secondary outcome [1] 0 0
Demonstrate the time to complete an emu™ Brain Scan is <15 minutes
Assessment method [1] 0 0
Timepoint [1] 0 0
<30 minutes from acute baseline CT/MRI
Secondary outcome [2] 0 0
Evaluate safety of the device
Assessment method [2] 0 0
Timepoint [2] 0 0
<30 minutes from acute baseline CT/MRI
Secondary outcome [3] 0 0
Evaluate usability of the device
Assessment method [3] 0 0
Timepoint [3] 0 0
<30 minutes from acute baseline CT/MRI
Secondary outcome [4] 0 0
Evaluate device deficiencies
Assessment method [4] 0 0
Timepoint [4] 0 0
<30 minutes from acute baseline CT/MRI

Eligibility
Key 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 -
Minimum age
22 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 -

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/11/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
EMVision Medical Devices Ltd
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Reade De Leacy, MBBS(Hons) FRANZCR
Address 0 0
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
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christian Wight, PhD
Address 0 0
Country 0 0
Phone 0 0
61 (0) 490 109 797
Email 0 0
cwight@emvision.com.au
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Informed consent form https://cdn.clinicaltrials.gov/large-docs/22/NCT06999122/ICF_000.pdf


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06999122