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Trial registered on ANZCTR


Registration number
ACTRN12623000070639
Ethics application status
Approved
Date submitted
24/11/2022
Date registered
20/01/2023
Date last updated
16/04/2024
Date data sharing statement initially provided
20/01/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
EMVision CP2/Gen 1 Brain Scanner Device Study on Acute Stroke Participants.
Scientific title
3-Stage, Multi-Centre, Study of the EMVision CP2/Gen 1 BrainScanner to Collect Data for Hardware Verification and Software Development for Imaging Acute Stroke from Healthy Participants and Participants Presenting with Stroke Symptoms to the Emergency Department.
Secondary ID [1] 308317 0
EMV-CIP-02
Universal Trial Number (UTN)
Trial acronym
The EMView Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 328286 0
Condition category
Condition code
Stroke 325333 325333 0 0
Haemorrhagic
Stroke 325334 325334 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stage 1 (Healthy Participants): After written informed consent has been acquired a physical examination will be performed followed by confirmation of the inclusion/exclusion criteria. After participant enrollment an MRI and the microwave signal will be obtained. Analysis of data for software development will be performed by comparing the microwave signal with the MRI as ground truth.

Stage 2/3: This stage will enroll participants with clinical signs of stroke in the acute phase (< 24 hours from onset of symptoms) admitted for CT scan. The inclusion/exclusion criteria will be assessed and if the participant is confirmed to be suitable for the trial, the participant will be asked to consent. If the answer is affirmative, the microwave scan will be performed. The procedure will take less than 15 minutes (the duration of the actual measurements is < 1 minute) and will not interfere with the patient's standard of care in the Emergency Department. For confirmed stroke patients, all follow-up standard of care CT/MRI scans will have a follow-up microwave scan up to 28 days from onset of symptoms or discharge.

Analysis of data for software development will be performed by comparing the microwave signal with the CT/MRI as ground truth.

CP2 Scanning Procedure: each CP2 scanning event involves two brain scans. The participant will be placed in prone position on an exam bed. The fiducial marker will be positioned above participants nose bridge and centered between the eyes. A disposable surgical cap will be placed on the participants head. Two staff members will be needed to operate the scanner – one person to ensure the fit and positioning of headset is correct and operate the machine, the other person to support the participants head and neck during placement of the headset. Once the participants positioning is correct, the membrane in the headset will be filled with a specific coupling medium to allow the headset to conform around the participants head. The membrane is made of silicone and will feel cool to the participant. Once the headset membrane is filled, the device will automatically begin first scan. Participants must remain very still during the scanning procedure. After the 1st scan is completed, the position of headset is adjusted and a 2nd scan is completed. After completion of the two CP2 scans, the headset membrane will deflate, and the headset, fiducial marker and surgical cap are removed.

CP2 Scan Duration: The entire set up and scanning process including fitting of the headset will take less than 15 minutes. Actual scan time is < 30 seconds per scan.

CP2 Scan Operators: After device user training has been undertaken for each expected operator of the device, study doctors which may include emergency room doctors, ICU doctors and study assigned registered nurses, will be delegated by the principal investigator to perform the CP2 brain scan procedure.
Intervention code [1] 324921 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable. This study is not diagnosing nor treating and is not comparing to a control. It is gathering data in order to refine the software of the device, which will be used in a validation study to assess efficacy of diagnosis.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333198 0
Per protocol, this is a data gathering study with the primary outcome being the acquisition of a dataset of healthy participants and stroke participants scans which will improve the understanding of stroke on electromagnetic scattering effects in the brain.

There is no diagnostic nor interventional outcome for this study.

The dataset will enable artificial intelligence and imaging algorithms to be advanced. This will then lead to a study with efficacy outcomes. All dataset acquisitions will be assessed as a composite primary outcome.
Timepoint [1] 333198 0
Stage 1: 30 datasets from healthy participants will provide sufficient information to meet the primary endpoint. The time to achieve this is approx. 2 months. Stage 2: 150 datasets from participants presenting to the emergency department with stroke symptoms provides the initial dataset upon which the final sample size is determined to meet the primary outcome. The time to achieve this is approx. 12 months. Stage 3: up to 30 datasets from confirmed haemorrhagic stroke participants who had presented to the emergency department, as well as datasets from other participants who had also presented to the emergency department with stroke symptoms prior to meeting the minimum datasets for the haemorrhagic stroke group. Following review of the Stage 2 dataset, it has been determined that the additional dataset per Stage 3 will provide sufficient information to meet the primary endpoint. The time to achieve this is approx. 12 months.
Secondary outcome [1] 416117 0
To evaluate the safety of the device.

There are no known adverse events at this time. Adverse events that are unlikely but possible include headache or discomfort from the placement of the scanner. Adverse events will be collected based on clinical evaluation at the time of the scanning and during the participant's participation in the study.
Timepoint [1] 416117 0
Adverse events will be assessed during the time of scanning with the EMVision Gen 1 Brain Scanner.
Secondary outcome [2] 416118 0
To obtain serialised data sets relating to the progression of stroke from stroke participants (data sets subsequent to the index DATA SET) from the EMVision Gen 1 Brain Scanner.
Timepoint [2] 416118 0
Stroke participants will receive a microwave scan each time they receive a standard of care CT/MRI for 28 days from onset of symptoms or until they are discharged, whichever is first.
Secondary outcome [3] 416119 0
Confirm with the hardware verification project that EMVision Gen 1 Brain Scanner will deliver successful scans on at least 80% of scans performed on healthy participants. A successful scan is defined as the completion of the defined programed workflow on a confirmed suitable participant.
Timepoint [3] 416119 0
Datasets from 30 healthy participants will provide sufficient information to meet the secondary endpoints. The time to achieve this is approx. 2 months. Cumulative data taken at the time of the microwave scan will be assessed at the conclusion of the study,

Eligibility
Key inclusion criteria
Arm A
1. Adults greater than or equal to 18 years of age.
2. Ability to provided informed consent
3. Head size deemed suitable for scanning with the EMVision Gen 1 Brain Scanner.

Arms B-F
1. Adults greater than or equal to 18 years of age.
2. Presenting to hospital with acute neurological deficit suspected to be stroke and within 24 hours of symptom onset
3. The use of the EMVision Gen 1 Brain Scanner will not delay the treatment of the participant
4. CT brain imaging following clinical evaluation in Emergency Department per standard of care
5. Ability to provide informed consent. Participants will provide written informed consent. Where this is not possible, consent from a legal authorized representative will be obtained.
6. Head size deemed suitable for scanning with the EMVision Gen 1 Brain Scanner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Arm A
1. History of neurological conditions (i.e., tumour, prior stroke, trauma etc)
2. Pregnant or breast feeding
3. Clinical signs or symptoms of stroke or other neurological conditions
4. Contraindication to neuroimaging, such conditions that prohibits MRI.
5. Presence of any implanted electro-stimulating devices in the head and neck.
6. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh etc (Note that small metallic objects, such an aneurysm coils etc, are acceptable)
7. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device
8. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries etc).
9. Is unable to lie still for the duration of the scan.
10. Any other condition or symptoms preventing the participant from entering the study, according to the investigator´s judgment.

Arms B-F
1. Has received treatment for current (suspected) stroke event prior to initial CT scan AND EMVision Gen 1 Brain Scanner scan.
2. Pregnant or breast feeding
3. Contraindication to neuroimaging, such as a contrast allergy or other condition that prohibits CT, MRI and/or angiography.
4. Presence of any implanted electro-stimulating devices in the head and neck
5. Presence of any large metallic craniofacial implants, such as bone fixation plates, mesh etc. (Note that small metallic objects, such an aneurysm coils etc, are acceptable)
6. Presence of an intracranial pressure monitor or any other similar sensor that may compromise the placement of the investigational device.
7. Inability to wear the investigational device (skin lesions on scalp, previous intracranial surgeries etc).
8. Is unable to lie still for the duration of the scan.
9. 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study is a multicentre, 6 Arm, observational study of healthy participants and participants who present to the Emergency Department with stroke symptoms whose data would be used to advance the software component of the device. No intervention or modification to the standard of care hospital-based treatment is proposed as part of this trial.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a traditional feasibility study for data acquisition, and not intended to be interventional study. The sample size was not determined by statistical considerations. 30 healthy participants will be enrolled Arm A and up to 320 participants presenting with stroke symptoms to the Emergency Department will be enrolled in Arms B-F collectively. These numbers are based upon engineering considerations and the number of cases likely required to advance the artificial intelligence algorithms.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/12/2022
Date of last participant enrolment
Anticipated
28/02/2025
Actual
Date of last data collection
Anticipated
28/03/2025
Actual
Sample size
Target
350
Accrual to date
209
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 23635 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 23636 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 23637 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 39055 0
2170 - Liverpool
Recruitment postcode(s) [2] 39056 0
3050 - Parkville
Recruitment postcode(s) [3] 39057 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 312561 0
Commercial sector/Industry
Name [1] 312561 0
EMVision Medical Devices Ltd
Country [1] 312561 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EMVision Medical Devices Ltd
Address
Suite 4.01, 65 Epping Road,
Macquarie Park NSW 2113
Country
Australia
Secondary sponsor category [1] 314168 0
None
Name [1] 314168 0
Address [1] 314168 0
Country [1] 314168 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311890 0
South Western Sydney Local Health District (SWSLHD) - Ethics Committee
Ethics committee address [1] 311890 0
Ethics committee country [1] 311890 0
Australia
Date submitted for ethics approval [1] 311890 0
30/06/2022
Approval date [1] 311890 0
29/09/2022
Ethics approval number [1] 311890 0
2022/ETH01235

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

Contacts
Principal investigator
Name 122734 0
Prof Dennis Cordato
Address 122734 0
Neurophysiology Department
Clinic 111, Level 1, Clinical Services Building, Liverpool Hospital,
Corner of Elizabeth and Goulburn Streets
Liverpool NSW 2170
Country 122734 0
Australia
Phone 122734 0
+61287383646
Fax 122734 0
Email 122734 0
[email protected]
Contact person for public queries
Name 122735 0
Scott Kirkland
Address 122735 0
EMVision Medical Devices Ltd
Suite 4.01, 65 Epping Road,
Macquarie Park NSW 2113
Country 122735 0
Australia
Phone 122735 0
+6128667 5337
Fax 122735 0
Email 122735 0
[email protected]
Contact person for scientific queries
Name 122736 0
Christian Wight
Address 122736 0
EMVision Medical Devices Ltd
Suite 4.01, 65 Epping Road,
Macquarie Park NSW 2113
Country 122736 0
Australia
Phone 122736 0
+6128667 5337
Fax 122736 0
Email 122736 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Analysis of these study data will be conducted internally by the research team, and IPD will not be not publicly shared.


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.