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Trial registered on ANZCTR
Registration number
ACTRN12623000820606
Ethics application status
Approved
Date submitted
30/05/2023
Date registered
1/08/2023
Date last updated
1/08/2023
Date data sharing statement initially provided
1/08/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Feasibility and clinical accuracy of novel robot-assisted, remotely-performed abdominal ultrasound examination
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Scientific title
Feasibility and clinical accuracy of novel robot-assisted, remotely-performed abdominal ultrasound examination
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Secondary ID [1]
309760
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Internal Medicine, Thoracic and Gastrointestinal diseases
330164
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Condition category
Condition code
Oral and Gastrointestinal
327040
327040
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Procedure - Utilisation of existing clinically used abdominal 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)
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Intervention code [1]
326204
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Diagnosis / Prognosis
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Comparator / control treatment
Procedure performed with sonographer manipulating 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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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 the major assessments (and the respective individual measurements) of organ structure and function associated with standard clinical abdominal ultrasound examination,
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Assessment method [1]
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Timepoint [1]
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Assessment of primary outcome occurs during examination session - intervention and control procedure performed back to back respectively.
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Primary outcome [2]
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Accuracy of novel ultrasound method - Measurements on acquired images - Robot manipulation of probe to acquire images (intervention)
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Assessment method [2]
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Timepoint [2]
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Assessment of primary outcome occurs during examination session - intervention and control procedure performed back to back respectively.
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Secondary outcome [1]
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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)
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Assessment method [1]
422382
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Timepoint [1]
422382
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Assessment of secondary outcome occurs during examination session - intervention and control procedure performed back to back respectively.
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Eligibility
Key inclusion criteria
equal to or greater than 18yrs old, willing and able to participate
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
under 18yrs old, unwilling and/or unable to participate, known current acute or non-acute disease or condition associated with:
pancreas
aorta
liver
gall bladder
common bile duct
portal vein
kidneys
spleen
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Other
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Other design features
all participants will receive both the novel and current methods
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2023
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Actual
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Date of last participant enrolment
Anticipated
29/12/2023
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Actual
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Date of last data collection
Anticipated
29/03/2024
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
40460
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Queensland Health
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Address [1]
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Royal Brisbane and Women's Hospital
Butterfield Street, Herston 4029, Queensland
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Country [1]
313951
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Australia
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Primary sponsor type
Commercial sector/Industry
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Name
RMI Oceania Pty Ltd
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Address
Level 1/23-27 Wellington St, St Kilda VIC 3182
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
316209
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Country [1]
316209
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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HREC A Metro North Hospital and Health Service
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Ethics committee address [1]
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Metro North Office of Research
Metro North Health
Level 7, Block 7
Butterfield Street, Herston Qld 4029
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Ethics committee country [1]
313088
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Australia
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Date submitted for ethics approval [1]
313088
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16/03/2022
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Approval date [1]
313088
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27/05/2022
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Ethics approval number [1]
313088
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84700
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Summary
Brief summary
This research study aims to investigate and establish the feasibility, clinical accuracy of remotely-performed, robot-assisted abdominal ultrasound examination performed by general sonographers.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Kristyan Guppy-Coles
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Address
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Royal Brisbane and Women's Hospital
Butterfield Street, Herston Qld 4029
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Country
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Australia
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Phone
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+61438758378
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Kristyan Guppy-Coles
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Address
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Royal Brisbane and Women's Hospital
Butterfield Street, Herston Qld 4029
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Country
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Australia
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Phone
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+61438758378
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Kristyan Guppy-Coles
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Address
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Royal Brisbane and Women's Hospital
Butterfield Street, Herston Qld 4029
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Country
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Australia
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Phone
126960
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+61438758378
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Fax
126960
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Email
126960
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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