Automated Ultrasound Cardiac Guidance Tool

Recruiting

• Conditions: Ultrasound Imaging

• Registration Number: NCT05649826
• Lead Sponsor: UltraSight

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

Study Timeline

• Study First Submitted: 2022-04-03
• Study First Submitted QC: 2022-12-05
• Study First Posted: 2022-12-14
• Study Start: 2023-02-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-21
• Primary Completion: 2027-05-01
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
6. Subjects with BMI above 40.
7. Subjects experiencing a known or suspected acute cardiac event.
8. Subjects with severe chest wall deformity as per previous medical records and physical examination.
9. Subjects who have undergone pneumonectomy.
10. 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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Wayne University; 🇺🇸 Detroit, Michigan, United States