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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
Date last updated
19/12/2024
Titles & IDs
Public title
Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)
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Scientific title
Echocardiographic Acquisition With Geographic Separation of Patients and Sonographers With Roboot Assistance (EAGER)
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Secondary ID [1]
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BakerHeartDiabetesI
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Universal Trial Number (UTN)
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Trial acronym
EAGER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Echocardiography
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Diagnosis / Prognosis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion complete
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Assessment method [1]
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Proportion of a standard acquisition protocol obtainable using robotic acquisition over 1 hour
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Timepoint [1]
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1 hour
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Secondary outcome [1]
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Proportion complete
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Assessment method [1]
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Proportion of echo views with the same information provided by conventional echo
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Timepoint [1]
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1 hour
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Secondary outcome [2]
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Proportion diagnostic features correctly identified by robotic echo
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Assessment method [2]
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Proportion diagnostic features correctly identified by robotic echo
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Timepoint [2]
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1 hour
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Eligibility
Key inclusion criteria
* Having a conventional echocardiogram
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Declined consent to undergo both examinations
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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 analysing the results/data
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Intervention assignment
Other
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
15/01/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Baker Heart and Diabetes Institute
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Echocardiography is a cornerstone of modern cardiology management, but access in rural and remote areas is limited. We have developed a robot ("Edler" named after the originator of echocardiography) which enables a sonographer to complete an examination at a distance. This study seeks to compare the images obtained by both methods, the completeness of the exam over a feasible time, and to identify particular components of the exam that are difficult to obtain using the robot.
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Trial website
https://clinicaltrials.gov/study/NCT06742905
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Thomas H Marwick, MBBS, PhD, MPH
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Address
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Country
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Phone
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0385321550
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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
Data sharing statement
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
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