Automated Ultrasound Cardiac Guidance Tool | NCT05649826

Studies
Automated Ultrasound Cardiac Guidance Tool

NCT05649826

Sponsor

UltraSight

Status

Recruiting

Last Update Posted

May 21, 2024Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Ultrasound Imaging

Interventions

Not provided

Countries

United States

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

May 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Actual

Primary Completion Date

May 1, 2027Estimated

Completion Date

May 1, 2027Estimated

First Submitted Date

Apr 3, 2022

First Submission Date that Met QC Criteria

Dec 5, 2022

First Posted Date

Dec 14, 2022Actual

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

May 20, 2024

Last Update Posted Date

May 21, 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

This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed

Detailed Description

The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acquisition of transthoracic echocardiography media from up to 200 subjects	Several echocardiography views will be acquired from the participants, with in several acoustic windows and views	up to 5 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females, aged 18 years and older
Subject willing and able to give written informed consent

Exclusion Criteria:

Emergency (non-elective) admission within 24 h prior to participating in the study
Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
Subjects with BMI above 40.
Subjects experiencing a known or suspected acute cardiac event.
Subjects with severe chest wall deformity as per previous medical records and physical examination.
Subjects who have undergone pneumonectomy.
Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Up to 200 subjects will be enrolled in this study, at least 35% females and 35% males.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert Ehrman, MD	Contact	313-5771268		rehrman@med.wayne.edu
Laura Gowland, Sonographer	Contact	313-5771268		lgowland@med.wayne.edu

Overall Officials

Name	Affiliation	Role
Robert Ehrman, MD	Wayne University Emergency medicine	Principal Investigator
Noa Avisar, PhD	UltraSight	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wayne University	Recruiting	Detroit	Michigan	48201	United States