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Not yet recruitingNCT06742905EAGERUpdated Dec 19, 2024

Echo Acquisition Despite Geographic Separation by Replication of Human Movements (EAGER)

An interventional study of Robot-guided echo and Standard echocardiogram in Echocardiography, sponsored by Baker Heart and Diabetes Institute. Not yet recruiting at 1 site in Australia. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by Baker Heart and Diabetes Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the detailed description

The EAGER study is an effectiveness and feasibility trial of robot -assisted echo.

Patients who have undergone a standard echo will be asked to have a repeat study with a different sonographer, working remotely, obtaining images using the robot. This study is limited to 1 hour and as many views as possible will be obtained. During the study, the remote sonographer and patient are in direct contact over a video link. Another person will be in the room with the patient and the patient will be instructed on the use of a stop switch which will disengage the robot if they feel uncomfortable.

The acquired images will be saved to the imaging cloud and interpreted by an imaging specialist blinded to the original echocardiogram. A side-by-side comparison will be undertaken for each view, and image quality and study completeness will be assessed.

02

Conditions studied

  • Echocardiography

Keywords

  • Echocardiography
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Having a conventional echocardiogram

Exclusion criteria

Exclusion Criteria:

  • Declined consent to undergo both examinations
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
Single (Investigator)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Standard echo

    Standard echo exam provided by a sonographer using a standard view template

    Diagnostic Test: Standard echocardiogram

  • Experimental
    Robotic echo

    Robotic echo exam provided by a sonographer using a standard view template

    Diagnostic Test: Robot-guided echo

Interventions

  • Diagnostic testRobot-guided echo

    This echo will be performed by a remote sonographer, though a robot

  • Diagnostic testStandard echocardiogram

    Echocardiogram acquired by a sonographer at the patient's bedside

05

What researchers measure

Primary outcomes

  1. Proportion complete

    Proportion of a standard acquisition protocol obtainable using robotic acquisition over 1 hour

    Time frame: 1 hour

Secondary outcomes

  1. Proportion complete

    Proportion of echo views with the same information provided by conventional echo

    Time frame: 1 hour

  2. Proportion diagnostic features correctly identified by robotic echo

    Proportion diagnostic features correctly identified by robotic echo

    Time frame: 1 hour

06

Study locations

1 site
  • Baker Heart and Diabetes Institute
    Melbourne, Victoria 3004, Australia
    • Leah Wright, BSc, PhD · Contact · leah.wright@baker.edu.au · +61 3 8532 1550
    • Elizabeth Dewar, BSc · Contact · liz.dewar@baker.edu.au · +61 3 8532 1550
    • Thomas Marwick, MBBS, PhD, MPH · Principal investigator
    • Mats Isaksson, PhD · Sub investigator
07

References and documents

Individual participant data

Plan to share: Yes — De-identified individual participant data that underlie the results reported in this project (text, tables, figures and appendices) will be made available.

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06742905
Lead sponsor
Baker Heart and Diabetes Institute
Responsible party
Sponsor
First posted
Dec 19, 2024
Start date
Jan 15, 2025 (estimated)
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 19, 2024

Study contacts

Thomas H Marwick, MBBS, PhD, MPH
Contact
tom.marwick@baker.edu.au
0385321550

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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