Recruiting

Ultrasound Cardiac Guidance

Sponsor:

UltraSight

Code:

NCT05649826

Conditions

Ultrasound Imaging

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Ultrasound Imaging

Study ID

NCT05649826

Start date

Feb 1, 2023

Status verified date

May, 2024

Completion date

May 1, 2027

Anticipated

Primary completion date

May 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Acquisition of transthoracic echocardiography media from up to 200 subjects [ Time Frame: up to 5 year ]

Central Contacts and Locations

Central contacts

Locations

Wayne University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Laura Gowland, sonographer

313-577-1268lgowland@med.wayne.edu

Principal Investigator:

Robert Ehrman, MD

More Information

Sponsor

UltraSight

Last update posted

May 21, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by UltraSight on 2024-05-21.