Optimization of an Ultrasound Cardiac Guidance Tool

UltraSight1 site in 1 country200 target enrollmentFebruary 1, 2023

ConditionsUltrasound Imaging

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ultrasound Imaging
Sponsor: UltraSight
Enrollment: 200
Locations: 1
Primary Endpoint: Acquisition of transthoracic echocardiography media from up to 200 subjects
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 1, 2023

End Date

May 1, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

UltraSight

Responsible Party

Sponsor

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
•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.).