Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001476527
Ethics application status
Approved
Date submitted
28/11/2024
Date registered
18/12/2024
Date last updated
18/12/2024
Date data sharing statement initially provided
18/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Data Collection Study of the EMVision emu™ Brain Scanner of Patients Not Experiencing Stroke for Software Algorithm Development Purposes
Scientific title
Data Collection Study of the EMVision emu™ Brain Scanner of Patients Not Experiencing Stroke for Software Algorithm Development Purposes
Secondary ID [1] 313480 0
HHT-06
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 335893 0
Condition category
Condition code
Stroke 332478 332478 0 0
Haemorrhagic
Stroke 332479 332479 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a data collection study for the purposes of training software algorithms.

Participants who have recently received an head MRI as part of their routine care will receive two emu™ brain scans. 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 following the MRI brain scan. Each visit takes up to one hour and consists of two scan procedures conducted by a qualified nurse or physician, taking ten minutes each. Nurses and physicians responsible for conducting scans will receive two hours of face-to-face training or refresher training with EMVision trainers 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.

Study participation is considered complete following the second emu™ brain scan; no follow-up visits or reporting is required.
Intervention code [1] 330061 0
Diagnosis / Prognosis
Intervention code [2] 330173 0
Treatment: Devices
Comparator / control treatment
Participants will act as their own control. The comparator MRI scan and its associated duration is at the determination of the participants’ physicians, typically approximately 30 minutes; this study does not require any additional interventions to their standard-of-care MRI.
Control group
Active

Outcomes
Primary outcome [1] 340020 0
Specificity of EMVision brain scanner
Timepoint [1] 340020 0
Baseline emu™ brain scan
Secondary outcome [1] 442351 0
Repeatability of EMVision brain scan.
Timepoint [1] 442351 0
Baseline emu™ brain scan
Secondary outcome [2] 442818 0
Reproducibility of EMVision brain scan.
Timepoint [2] 442818 0
Baseline emu™ brain scan

Eligibility
Key inclusion criteria
Ability to freely provide informed consent, able to speak English, and read written English.
Head size deemed suitable for scanning with the emu™ brain scanner.
Completed an MRI of the head (including both T1 and T2 sequences), where the MRI identified no significant abnormalities, within the last 24 hours.
Participation in the research study will not delay the treatment of the participant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or breastfeeding.
Known presence of medical implantation in the head.
Known neck conditions/injuries.
Neurological condition that presents with significant abnormalities in an MRI of the head.

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
19/12/2024
Actual
Date of last participant enrolment
Anticipated
16/10/2026
Actual
Date of last data collection
Anticipated
16/10/2026
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27370 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 43464 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 317922 0
Commercial sector/Industry
Name [1] 317922 0
EMVision
Country [1] 317922 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EMVision
Address
Country
Australia
Secondary sponsor category [1] 320273 0
None
Name [1] 320273 0
Address [1] 320273 0
Country [1] 320273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316607 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 316607 0
Ethics committee country [1] 316607 0
Australia
Date submitted for ethics approval [1] 316607 0
29/02/2024
Approval date [1] 316607 0
17/10/2024
Ethics approval number [1] 316607 0

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

Contacts
Principal investigator
Name 138398 0
A/Prof Dennis Cordato
Address 138398 0
Liverpool Hospital, Burnside Drive, Liverpool, NSW 2170
Country 138398 0
Australia
Phone 138398 0
+61 287383646
Fax 138398 0
Email 138398 0
dennis.cordato@health.nsw.gov.au
Contact person for public queries
Name 138399 0
Christian Wight
Address 138399 0
EMVision Medical Devices Ltd., Suite 4.01, 65 Epping Road, Macquarie Park NSW 2113
Country 138399 0
Australia
Phone 138399 0
+61 28667 5337
Fax 138399 0
Email 138399 0
cwight@emvision.com.au
Contact person for scientific queries
Name 138400 0
Christian Wight
Address 138400 0
EMVision Medical Devices Ltd., Suite 4.01, 65 Epping Road, Macquarie Park NSW 2113
Country 138400 0
Australia
Phone 138400 0
+61 28667 5337
Fax 138400 0
Email 138400 0
cwight@emvision.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.