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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06742905




Registration number
NCT06742905
Ethics application status
Date submitted
16/12/2024
Date registered
19/12/2024

Titles & IDs
Public title
Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)
Scientific title
Echocardiographic Acquisition With Geographic Separation of Patients and Sonographers With Roboot Assistance (EAGER)
Secondary ID [1] 0 0
BakerHeartDiabetesI
Universal Trial Number (UTN)
Trial acronym
EAGER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Echocardiography 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Robot-guided echo
Diagnosis / Prognosis - Standard echocardiogram

Active comparator: Standard echo - Standard echo exam provided by a sonographer using a standard view template

Experimental: Robotic echo - Robotic echo exam provided by a sonographer using a standard view template


Diagnosis / Prognosis: Robot-guided echo
This echo will be performed by a remote sonographer, though a robot

Diagnosis / Prognosis: Standard echocardiogram
Echocardiogram acquired by a sonographer at the patient's bedside
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion complete
Timepoint [1] 0 0
1 hour
Secondary outcome [1] 0 0
Proportion complete
Timepoint [1] 0 0
1 hour
Secondary outcome [2] 0 0
Proportion diagnostic features correctly identified by robotic echo
Timepoint [2] 0 0
1 hour

Eligibility
Key inclusion criteria
* Having a conventional echocardiogram
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Declined consent to undergo both examinations

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
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Baker Heart and Diabetes Institute
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Thomas H Marwick, MBBS, PhD, MPH
Address 0 0
Country 0 0
Phone 0 0
0385321550
Fax 0 0
Email 0 0
tom.marwick@baker.edu.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data that underlie the results reported in this project (text, tables, figures and appendices) will be made available.

Supporting document/s available: Study protocol
When will data be available (start and end dates)?
Dates - material will be made available immediately following publication, with no end date.
Available to whom?
The authors are pleased to collaborate with other researchers who provide a methodologically sound proposal, to achieve the aims of the approved proposal, including individual participant data meta-analysis.

Proposals should be directed to tom.marwick@baker.edu.au. To gain access, data requestors will need to sign a data access agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.baker.edu.au/research/laboratories/imaging-research


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06742905