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

NCT06742905 | Not Yet Recruiting

• 1 other identifier: BakerHeartDiabetesI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Echocardiography

Keywords

Echocardiography

Outcome Measures

Primary Outcomes (1)

• Proportion complete

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

  1 hour

Secondary Outcomes (2)

• Proportion complete

  1 hour

• Proportion diagnostic features correctly identified by robotic echo

  1 hour

Study Arms (2)

Standard echo

ACTIVE COMPARATOR

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

Diagnostic Test: Standard echocardiogram

Robotic echo

EXPERIMENTAL

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

Diagnostic Test: Robot-guided echo

Interventions

Robot-guided echo DIAGNOSTIC_TEST

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

Robotic echo

Standard echocardiogram DIAGNOSTIC_TEST

Echocardiogram acquired by a sonographer at the patient's bedside

Standard echo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having a conventional echocardiogram

You may not qualify if:

• Declined consent to undergo both examinations

Sponsors & Collaborators

• Baker Heart and Diabetes Institute: lead

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

Location

Central Study Contacts

Thomas H Marwick, MBBS, PhD, MPH

CONTACT

0385321550; tom.marwick@baker.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: January 15, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Dates - material will be made available immediately following publication, with no end date.
• Access Criteria: 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.

Locations

AU (1)