Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000437460
Ethics application status
Approved
Date submitted
23/04/2025
Date registered
12/05/2025
Date last updated
12/05/2025
Date data sharing statement initially provided
12/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
EMVision emu™ Brain Scanner on Acute Stroke and Intracranial Haemorrhage
Scientific title
Continuous Innovation Study of the EMVision emu™ Brain Scanner in the Diagnosis of Acute Stroke and Intracranial Haemorrhage
Secondary ID [1] 314161 0
EMV-CIP-04
Universal Trial Number (UTN)
Trial acronym
The EMView-2 Study
Linked study record
ACTRN12619001684112

This 'EMView-2' innovation study aims to add additional capabilities to the emu™ Brain Scanner algorithms produced from the previous 'EMView' study.

Health condition
Health condition(s) or problem(s) studied:
Stroke 336994 0
Condition category
Condition code
Stroke 333460 333460 0 0
Haemorrhagic
Stroke 333461 333461 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a continued innovation study for the development of additional software features for the emu™ Brain Scanner.

Participants who present to the hospital suspected of suffering from a suspected stroke or intracranial haemorrhage will receive an emu™ brain scan. emu™ device brain scans measure the dielectric properties of the brain using non-invasive, non-ionising, low-energy, electromagnetic pulses.

During an emu™ brain scan procedure, the emu™ is brought bedside to a participant lying supine on a hospital bed. A headset housing an array of antennae is placed on the head, where the headset membrane inflates with a coupling fluid to conform to the shape of the head during which the scans take place.

Participation in this study consists of a single visit taking place in the hospital and consists of a single brief scan procedure (typically under six minutes) conducted by a qualified nurse or physician. Study participation is considered complete upon positive radiological confirmation of the presenting condition, patient discharge, or 28 days, whichever is earliest. No procedures are required of the participant following the initial emu™ brain scan.

Nurses and physicians responsible for conducting scans will receive two hours of face-to-face training or refresher training with EMVision trainers approximately one week prior to enrolment of the first participant. All scan data is reviewed by EMVision engineers to verify scanning procedures are conducted to an appropriate standard.
Intervention code [1] 330759 0
Diagnosis / Prognosis
Intervention code [2] 330761 0
Treatment: Devices
Comparator / control treatment
Participants will act as their own control. The comparator radiological imaging (either CT or MR imaging) and its associated duration is at the determination of the participants’ physicians and is part of the standard of care stroke workflow, typically approximately 30 minutes. The emu™ brain scan will be conducted within 30 minutes to neurological imaging, either prior to or immediately after imaging with priority given to standard-of-care imaging. Follow-up standard-of-care imaging within 28 days of presentation may be used to confirm the diagnosis should initial imaging results be inconclusive. This study does not require any additional interventions to their standard-of-care medical imaging.
Control group
Active

Outcomes
Primary outcome [1] 341107 0
Sensitivity of emu™ stroke detection algorithms when applied to the EMVision test dataset when compared to CT/MRI radiology reports.
Timepoint [1] 341107 0
Confirmation of diagnosis, or 28 days, whichever is earlier.
Secondary outcome [1] 446277 0
Safety of emu™ brain scanner
Timepoint [1] 446277 0
Baseline emu™ brain scan
Secondary outcome [2] 446278 0
Reliability of emu™ brain scanner
Timepoint [2] 446278 0
Baseline emu™ brain scan

Eligibility
Key inclusion criteria
Presenting to hospital with acute suspected stroke or intracranial haemorrhage (ICH) 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 planned or received following clinical evaluation in Emergency Department per standard of care.
Head size deemed suitable for scanning with the EMVision emu™ Brain Scanner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Has received treatment for current acute presentation event prior to initial CT/MRI scan or EMVision emu™ Brain Scanner scan (such as thrombolysis)
Contraindication to neuroimaging.
Known presence of medical implantation in the head.
Known neck conditions/injuries.
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
1/06/2026
Actual
Date of last data collection
Anticipated
1/06/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 27728 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 27729 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43917 0
2305 - New Lambton
Recruitment postcode(s) [2] 43918 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 318673 0
Commercial sector/Industry
Name [1] 318673 0
EMVision
Country [1] 318673 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EMVision
Address
Country
Australia
Secondary sponsor category [1] 321095 0
None
Name [1] 321095 0
Address [1] 321095 0
Country [1] 321095 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317286 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 317286 0
Ethics committee country [1] 317286 0
Australia
Date submitted for ethics approval [1] 317286 0
31/01/2025
Approval date [1] 317286 0
17/03/2025
Ethics approval number [1] 317286 0
2025/ETH00101

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140570 0
Dr Carlos Garcia-Esperon
Address 140570 0
John Hunter Hospital, Lookout Rd, New Lambton Heights NSW 2305
Country 140570 0
Australia
Phone 140570 0
+61 2 4921 3490
Fax 140570 0
Email 140570 0
[email protected]
Contact person for public queries
Name 140571 0
Christian Wight
Address 140571 0
EMVision Medical Devices Ltd., Suite 4.01, 65 Epping Road, Macquarie Park NSW 2113
Country 140571 0
Australia
Phone 140571 0
+61 2 8667 5337
Fax 140571 0
Email 140571 0
[email protected]
Contact person for scientific queries
Name 140572 0
Christian Wight
Address 140572 0
EMVision Medical Devices Ltd., Suite 4.01, 65 Epping Road, Macquarie Park NSW 2113
Country 140572 0
Australia
Phone 140572 0
+61 2 8667 5337
Fax 140572 0
Email 140572 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.