Automated Ultrasound Cardiac Guidance Tool

Ultrasound Imaging Clinical Trial

Official title:

Optimization of an Ultrasound Cardiac Guidance Tool

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649826
• Other study ID #: 002-30 US
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: May 1, 2027

Study information

• Verified date: May 2024
• Source: UltraSight
• Contact: Robert Ehrman, MD
• Phone: 313-5771268
• Email: rehrman[@]med.wayne.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Ultrasound Imaging

Locations

Country	Name	City	State
United States	Wayne University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
UltraSight

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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