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

NCT ID: NCT06742905

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Echocardiography

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Echocardiography

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard echo

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

Group Type ACTIVE_COMPARATOR

Standard echocardiogram

Intervention Type DIAGNOSTIC_TEST

Echocardiogram acquired by a sonographer at the patient's bedside

Robotic echo

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

Group Type EXPERIMENTAL

Robot-guided echo

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot-guided echo

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

Intervention Type DIAGNOSTIC_TEST

Standard echocardiogram

Echocardiogram acquired by a sonographer at the patient's bedside

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Having a conventional echocardiogram

Exclusion Criteria

* Declined consent to undergo both examinations
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Baker Heart and Diabetes Institute

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Baker Heart and Diabetes Institute

Melbourne, Victoria, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Thomas H Marwick, MBBS, PhD, MPH

Role: CONTACT

Phone: 0385321550

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Leah Wright, BSc, PhD

Role: primary

Elizabeth Dewar, BSc

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BakerHeartDiabetesI

Identifier Type: -

Identifier Source: org_study_id