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NCT Number: NCT06742905

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

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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Key information

Conditions

Echocardiography

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a conventional echocardiogram

Exclusion criteria

  • Declined consent to undergo both examinations

Treatment and study plan

Robot-guided echo

Diagnostic Test

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

Standard echocardiogram

Diagnostic Test

Echocardiogram acquired by a sonographer at the patient's bedside

Primary outcomes

  1. Proportion complete

    Time frame: 1 hour

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

Secondary outcomes

  1. Proportion complete

    Time frame: 1 hour

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

  2. Proportion diagnostic features correctly identified by robotic echo

    Time frame: 1 hour

    Proportion diagnostic features correctly identified by robotic echo

Study contacts

Contact information is provided by the study sponsor or research team.

Thomas H Marwick, MBBS, PhD, MPH

CONTACT

[email protected]

0385321550

Sponsors and collaborators

Lead sponsor

Baker Heart and Diabetes Institute

Other

Registry information

Official study title

Echocardiographic Acquisition With Geographic Separation of Patients and Sonographers With Roboot Assistance (EAGER)

Acronym: EAGER

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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