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Trial registered on ANZCTR


Registration number
ACTRN12619001684112
Ethics application status
Approved
Date submitted
21/11/2019
Date registered
2/12/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
An Early Feasibility Study to Obtain Imaging Data from Participants with
a Diagnosed Stroke to Refine the Algorithm for the EMVision Brain Scanner
Scientific title
An Early Feasibility Study to Obtain Imaging Data from Participants with
a Diagnosed Stroke to Refine the Algorithm for the EMVision Brain Scanner
Secondary ID [1] 299873 0
EMV-CIP-01
Universal Trial Number (UTN)
U1111-1244-3433
Trial acronym
Not applicable
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Stroke diagnosis 315285 0
Condition category
Condition code
Stroke 313582 313582 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once consent is documented, the participant would be further reviewed, and data such as demographics, medical history, vital signs, and NIH Stroke Scale will be collected, and physical exam will be performed. Physical exam, NIH Stroke Scale and vital signs be recorded and are part of triage process or hospital/emergency department acute care standard operating procedure.
CT/MRI would be conducted as part of standard diagnostics process of any patients presenting with stroke symptoms.
Stroke diagnosis would be made following the results of CT/MRI and whether of haemorrhagic stroke or ischemic stroke will be collected and recorded.

The EMV scanner unit consists of a portable headset (a crown housing an array of antennae, with a coupling-fluid filled bladder that inflates gently to make contact with the head), and computer with graphic user interface.

Within 72 hour, and ideally as close to the diagnostic scan time as feasible, the EMVision brain scanner will be placed on the participant’s head to acquire the first scan data. Each image acquisition from positioning, scanning and device removal will take approximately 10 minutes. Scanning will be undertaken by a member of the Neurology and/or Intensivist team after extensive training is undertaken and signed off by the Sponsor.
Actual image acquisition will take approximately 20 seconds. The participants will be positioned in a semi-recumbent position in the bed for scanning. A pillow will be placed behind the participant’s back to accommodate the head scanner such that the participant is kept as comfortable as possible during the scan.
Each EMVision scan will be performed in duplicate, user/performance data will be gathered, and image data recorded from both scans will be analysed for reproducibility/comparison.
The participants would be exposed to signal power intensities up to 10 mW which is within Federal Communications Commission standards. These frequencies are used in mobile communication, body scanners and many other daily life applications. The captured signals are then stored and processed using a laptop or tablet and subsequently analysed at the UQ ITT laboratory to generate an image of the head.
Follow up scans as above will be collected at approximately days 3-5, 6-8, and during the convalescence period, if clinically acceptable to do so, as deemed by the investigator. No more than five scans will be collected.
A participant’s involvement may last up to approximately 28 days as an inpatient or until discharge (whichever is sooner). A patient may be considered as 'completed' if a minimum of one EMVision digital can is conducted and is either followed to 28 days (or discharge, whichever is sooner) or passes away prior.
Intervention code [1] 316138 0
Diagnosis / Prognosis
Comparator / control treatment
Not applicable. This study is not diagnosing nor treating and is not comparing to a control. It is merely gathering data in order to refine the algorithm of the device, which will be used in a later study to then assess efficacy of diagnosis compared to gold standard (CT and/or MRI)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322038 0
Per protocol, this is a only a data gathering study with the primary outcome being the acquisition of a dataset of stroke patient scans which will improve the understanding of stroke on electromagnetic scattering effects in the brain.

There is no diagnostic nor interventional outcome for this initial study.

The dataset will enable the algorithms to be developed leading to image acquisition in the future. This will then lead to the next efficacy study.
Timepoint [1] 322038 0
The Research team estimates that 30 datasets from stroke patients will provide sufficient information to meet the primary endpoint. The time to achieve this is approx. 6 months.
Secondary outcome [1] 377129 0
1. Assessment of device-related adverse events.

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 patients participation in the study.
Timepoint [1] 377129 0
Adverse events will be assessed from the time of the initial scan through to the completion of the patient's participation in the study.
Secondary outcome [2] 377279 0
2. Assessment of operator feedback (ease of placement of device, interference with concomitant treatments) measured using Likert Scale (1-5).
Timepoint [2] 377279 0
Operator feedback will be obtained after each scan with the EMVision scanner.
Secondary outcome [3] 377280 0
3. Assessment of patient feedback or user’s observation of patient (discomfort, visual impediment, noise disturbance) measured using Likert Scale (1-5)
Timepoint [3] 377280 0
Patient feedback will be obtained after each scan with the EMVision scanner if clinically acceptable to obtain this.
Secondary outcome [4] 377281 0
4. Assessment of system readiness measured using Likert Scale (1-5)
Timepoint [4] 377281 0
System readiness data will be obtained during each scan with the EMVision scanner.
Secondary outcome [5] 377282 0
5. Assessment of time to complete scanning procedure (all scan data is timestamped /collected via the graphic user interface and software)
Timepoint [5] 377282 0
Assessment of time to complete scanning procedure data will be obtained following each scan with the EMVision scanner.
Secondary outcome [6] 377283 0
6. Number of meaningful images per scan as assessed by the Research team who are analysing the data the scanner is transmitting.
Timepoint [6] 377283 0
The Research team estimates that datasets from approximately 30 stroke patients will provide sufficient information to meet the secondary endpoints. The time to achieve this is approx. 6 months.
Secondary outcome [7] 377284 0
7. Assessment of device deficiencies as assessed by the operators of the equipment and the research team to whom the data is transmitted via the computer technology.
Timepoint [7] 377284 0
Assessment of device deficiencies will be assessed by the operators of the equipment and the research team each time a scan is performed with the EMVision unit.

Eligibility
Key inclusion criteria
1. Adults >=18 years of age.
2. Admitted to hospital with new neurological signs and confirmed diagnosis of stroke supported by conventional brain imaging.
3. Ability to provide informed consent. Participants will provide written informed consent. Where this is not possible, surrogate consent will be obtained.
4. Ability to adhere to study visit schedule and other protocol requirements.
5. Confirmed diagnosis of stroke within 72 hours of admission.
6. Head size deemed suitable for scanning with the EMVision brain scanner.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Experiences seizures from onset of stroke, or known history of seizure episodes.
2. Has injury or known medical condition on the head that would not allow the placement of EMVision brain scanner.
3. Is unable to lie still for the duration of the scan.
4. Is not a suitable candidate according to the assessing investigator.
5. Has any metal implants in the head or neck for example stents, aneurism clips, surgical clips, pressure monitors and drains.
6. Is known to be pregnant or lactating.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This study is a single-centre, two (2) groups, observational study of participants with a diagnosed stroke whose data would be used to refine the algorithm of the software component of the EMVision brain scanner. No intervention or modification to the usual hospital based treatment of stroke is proposed as part of this trial.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
This is a traditional early feasibility study for data acquisition, and not intended to be interventional study. The sample size was not determined by statistical considerations. Up to twenty (20) participants will be enrolled in each group: haemorrhagic stroke (group A) and ischaemic stroke (group B) with a total sample size of up to 30 completed patients. This is an estimate based upon engineering considerations and the number of cases likely required to refine the algorithm.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/12/2019
Actual
Date of last participant enrolment
Anticipated
29/05/2020
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15278 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28588 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304333 0
Commercial sector/Industry
Name [1] 304333 0
EMvision Medical Devices Ltd
Country [1] 304333 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
EMvision Medical Devices Ltd
Address
Level 10, 12 Creek Street
Brisbane QLD 4000
Country
Australia
Secondary sponsor category [1] 304580 0
None
Name [1] 304580 0
Address [1] 304580 0
Country [1] 304580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304784 0
Metro South HREC
Ethics committee address [1] 304784 0
Ethics committee country [1] 304784 0
Australia
Date submitted for ethics approval [1] 304784 0
09/11/2018
Approval date [1] 304784 0
21/03/2019
Ethics approval number [1] 304784 0
HREC/2018/QMS/48520

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

Contacts
Principal investigator
Name 98190 0
Dr David Cook
Address 98190 0
Intensive Care Unit
Princess Alexandra HOspital
Ipswich Road
Woolloongabba QLD 4120
Country 98190 0
Australia
Phone 98190 0
+61 7 3716 5150
Fax 98190 0
Email 98190 0
[email protected]
Contact person for public queries
Name 98191 0
Scott Kirkland
Address 98191 0
EMvision Medical Device Ltd
Level 10
12 Creek Street
Brisbane QLD 4000
Country 98191 0
Australia
Phone 98191 0
+61413991409
Fax 98191 0
Email 98191 0
[email protected]
Contact person for scientific queries
Name 98192 0
Ron Weinberger
Address 98192 0
EMvision Medical Device Ltd
Level 10
12 Creek Street
Brisbane QLD 4000
Country 98192 0
Australia
Phone 98192 0
+61406384189
Fax 98192 0
Email 98192 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.