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

Not Applicable

Not yet recruiting

• Conditions: Echocardiography

• Registration Number: NCT06742905
• Lead Sponsor: Baker Heart and Diabetes Institute

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.

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19
• Study Start: 2025-01-15
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Having a conventional echocardiogram

Exclusion Criteria

• Declined consent to undergo both examinations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Proportion complete	1 hour	Proportion of a standard acquisition protocol obtainable using robotic acquisition over 1 hour

Secondary Outcome Measures

Name	Time	Method
Proportion complete	1 hour	Proportion of echo views with the same information provided by conventional echo
Proportion diagnostic features correctly identified by robotic echo	1 hour	Proportion diagnostic features correctly identified by robotic echo

Trial Locations

Locations (1)

Baker Heart and Diabetes Institute; 🇦🇺 Melbourne, Victoria, Australia