Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000673640
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
22/06/2023
Date last updated
22/06/2023
Date data sharing statement initially provided
22/06/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and clinical accuracy of novel robot-assisted, remotely-performed echocardiographic examination
Scientific title
Feasibility and clinical accuracy of novel robot-assisted, remotely-performed echocardiographic examination
Secondary ID [1] 309757 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Disease 330163 0
Condition category
Condition code
Cardiovascular 327038 327038 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alternative format of non-invasive diagnostic procedure - cardiac ultrasound

Procedure - Utilisation of existing clinically used cardiac ultrasound systems where system probe is held by robotic arm. Sonographer utilises a gamepad to control the robotic arm system to acquire images.

Any ultrasound system is permitted, and a specific vendor is utilised based on the discretion of the hospital.

Sonographers will undergo a minimum of 15 hrs of virtual (software-based only) and hand-on simulator training, prior to human scanning.

Standard operation manuals are provided to ensure correct and standardised use of the system.

All participants will receive both procedures immediately after each other (consenting staff participants), or within 72hrs of each other (consenting patient participants); with the robotic arm used first and the manual probe used second (consenting staff participants), or the robotic arm used second after manual probe examination (performed for clinical purposes; sonographer blinded to the clinical exam)
Intervention code [1] 326203 0
Diagnosis / Prognosis
Comparator / control treatment
Traditional image acquisition method - Manipulation of probe by hand to acquire images.

All aspects of this procedure will be the same as those using the probe held by the robotic arm, including; the number and types of images acquired, and number and types of assessments performed.
Control group
Active

Outcomes
Primary outcome [1] 334904 0
Feasibility of novel ultrasound method - Robot manipulation of probe to acquire images (intervention)

Feasibility will be assessed based on ability to obtain both sufficient and valid images to perform each of the 10 major assessments of cardiac structure and function, and similar with the 37 individual measurements within.
Timepoint [1] 334904 0
Assessment of primary outcome occurs during examination session - intervention and control procedure performed back to back respectively.
Primary outcome [2] 335090 0
Accuracy of novel ultrasound method - Measurements on acquired images - Robot manipulation of probe to acquire images (intervention)

Accuracy will be assessed based on ability to obtain sufficient and valid measures from both sufficient and valid images to perform the 37 individual measurements comprising structure and function.
Timepoint [2] 335090 0
Assessment of primary outcome occurs during examination session - intervention and control procedure performed back to back respectively.
Secondary outcome [1] 422380 0
Assessment of efficiency of intervention - Time taken to perform all image acquisitions comprising a standard cardiac ultrasound examination (based on time between first and last image capture)
Timepoint [1] 422380 0
Assessment of secondary outcome occurs during examination session - intervention and control procedure performed back to back respectively.

Eligibility
Key inclusion criteria
equal to and greater than 18yrs old, willing and able to participate
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
under 18yrs old, unwilling and/or unable to participate, known current cardiac disease or condition

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)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
All participants will receive both the novel and current methods
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
27/06/2022
Date of last participant enrolment
Anticipated
29/12/2023
Actual
Date of last data collection
Anticipated
29/03/2024
Actual
Sample size
Target
100
Accrual to date
60
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24811 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 40458 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 313950 0
Government body
Name [1] 313950 0
Queensland Health
Country [1] 313950 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RMI Oceania Pty Ltd
Address
Level 1/23-27 Wellington St, St Kilda VIC 3182
Country
Australia
Secondary sponsor category [1] 316005 0
None
Name [1] 316005 0
Address [1] 316005 0
Country [1] 316005 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313087 0
HREC A Metro North Hospital and Health Service
Ethics committee address [1] 313087 0
Ethics committee country [1] 313087 0
Australia
Date submitted for ethics approval [1] 313087 0
16/03/2022
Approval date [1] 313087 0
27/05/2022
Ethics approval number [1] 313087 0
85278

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

Contacts
Principal investigator
Name 126954 0
Dr Kristyan Guppy-Coles
Address 126954 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston Qld 4029
Country 126954 0
Australia
Phone 126954 0
+61438758378
Fax 126954 0
Email 126954 0
[email protected]
Contact person for public queries
Name 126955 0
Kristyan Guppy-Coles
Address 126955 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston Qld 4029
Country 126955 0
Australia
Phone 126955 0
+61438758378
Fax 126955 0
Email 126955 0
[email protected]
Contact person for scientific queries
Name 126956 0
Kristyan Guppy-Coles
Address 126956 0
Royal Brisbane and Women's Hospital
Butterfield Street, Herston Qld 4029
Country 126956 0
Australia
Phone 126956 0
+61438758378
Fax 126956 0
Email 126956 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


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.