Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000979550
Ethics application status
Approved
Date submitted
24/07/2024
Date registered
12/08/2024
Date last updated
5/10/2024
Date data sharing statement initially provided
12/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and useability of a novel robot-assisted echocardiographic examination
Scientific title
Safety and useability of a novel robot-assisted echocardiographic examination in adults
Secondary ID [1] 312593 0
RMI-ROBOTECHO-CIP-002
Secondary ID [2] 312594 0
GCHREA 109986
Secondary ID [3] 312595 0
CT-2024-CTN-03777-1 v1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiac Disease 334519 0
Condition category
Condition code
Cardiovascular 331134 331134 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alternative format of non-invasive diagnostic procedure - cardiac ultrasound
a) Robot-assisted echocardiographic examination
b) Procedure - Utilisation of existing clinically used cardiac ultrasound systems where system probe is held by robotic arm.
c) Delivery - 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 echocardiogram scanning.

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

All participants of the study will have previously undergone (prior to consent) a clinically required standard of care manual echocardiographic examination. The robotically assisted echocardiographic examination will be conducted within 72 hours of the manual scan.
Intervention code [1] 329108 0
Diagnosis / Prognosis
Comparator / control treatment
Clinical standard of care manually performed image acquisition method - Manipulation of probe by hand to acquire images.
Control group
Active

Outcomes
Primary outcome [1] 338885 0
Safety of the robotic ultrasound assistance tool
Timepoint [1] 338885 0
1. Immediate safety events to be recorded during the procedure or immediately following, and
2. Follow up review, 72 hours post scan
Primary outcome [2] 338886 0
Useability (functionality) of using the of the robotic ultrasound assistance tool as intended to obtain echocardiogram images of clinically suitable quality for reporting by a cardiac sonographer
Timepoint [2] 338886 0
Assessment of primary outcome related to useability occurs immediately following the examination session.
Secondary outcome [1] 437794 0
NA
Timepoint [1] 437794 0
NA

Eligibility
Key inclusion criteria
1. Male or female aged 18 years or older
2. Inpatient or outpatient who has already received a routine (manual) echocardiogram that has been clinically reported.
3. Is willing to participate.
4. Provides written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Is pregnant.
2. Has poor patient mobility or is acutely symptomatic.

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
Safety
Statistical methods / analysis
The proportion of RUAT (Robotic ultrasound assistance tool) echocardiograms deemed to be of sufficient quality will be summarised descriptively along with a 95% confidence interval.
Participant experience will be summarised descriptively.
Adverse events and serious adverse events will be coded using the Medical Dictionary for Regulatory Affairs and will be summarised by system organ class and preferred term by echocardiogram type (conventional vs RUAT Echo). No statistical comparisons between adverse events or serious adverse events by scan type are planned.
Adverse device effects will be coded using the FDA Medical Device Report (MDR) adverse event codes and will be summarised by Level 1 Term and Level 3 Term by echocardiogram type (conventional vs RUAT Echo).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/10/2024
Actual
Date of last participant enrolment
Anticipated
30/11/2024
Actual
Date of last data collection
Anticipated
30/11/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26844 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 42906 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 316947 0
Commercial sector/Industry
Name [1] 316947 0
RMI Oceania Pty Ltd
Country [1] 316947 0
Australia
Funding source category [2] 317022 0
Government body
Name [2] 317022 0
Queensland Health
Country [2] 317022 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
RMI Oceania Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319267 0
None
Name [1] 319267 0
Address [1] 319267 0
Country [1] 319267 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315698 0
Gold Coast Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 315698 0
Ethics committee country [1] 315698 0
Australia
Date submitted for ethics approval [1] 315698 0
17/07/2024
Approval date [1] 315698 0
19/08/2024
Ethics approval number [1] 315698 0
109986

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

Contacts
Principal investigator
Name 135542 0
Prof John Atherton
Address 135542 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4006
Country 135542 0
Australia
Phone 135542 0
+61 736463257
Fax 135542 0
Email 135542 0
[email protected]
Contact person for public queries
Name 135543 0
Mathew Saliba
Address 135543 0
RMI Oceania, Wellington Street St Kilda, VIC 3182
Country 135543 0
Australia
Phone 135543 0
+61 413027376
Fax 135543 0
Email 135543 0
[email protected]
Contact person for scientific queries
Name 135544 0
Adam Scott
Address 135544 0
Royal Brisbane and Women's Hospital, Butterfield St, Herston QLD 4006
Country 135544 0
Australia
Phone 135544 0
+61 73646 8592
Fax 135544 0
Email 135544 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24223Study protocol    388121-(Uploaded-01-10-2024-09-15-39)-RMI-ROBOTECHO-CIP-002_V02_20240813_CLEAN.pdf
24224Informed consent form    388121-(Uploaded-01-10-2024-09-15-53)-RMI Pilot study PICF_V02_20240813_CLEAN.pdf



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.