Echo Acquisition Despite Geographic Separation by Replica... | NCT06742905

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

NCT06742905

Sponsor

Baker Heart and Diabetes Institute

Status

Not yet recruiting

Last Update Posted

Dec 19, 2024Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Echocardiography

Interventions

Robot-guided echo
Standard echocardiogram

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2025Estimated

Primary Completion Date

Dec 1, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Dec 16, 2024

First Submission Date that Met QC Criteria

Dec 16, 2024

First Posted Date

Dec 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 16, 2024

Last Update Posted Date

Dec 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Robot-guided echo	Diagnostic Test	This echo will be performed by a remote sonographer, though a robot	Robotic echo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion complete	Proportion of a standard acquisition protocol obtainable using robotic acquisition over 1 hour	1 hour

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Having a conventional echocardiogram

Exclusion Criteria:

Declined consent to undergo both examinations

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas H Marwick, MBBS, PhD, MPH	Contact	0385321550		tom.marwick@baker.edu.au

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baker Heart and Diabetes Institute		Melbourne	Victoria	3004	Australia

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

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.

URL

https://www.baker.edu.au/research/laboratories/imaging-research