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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05649826
Other study ID # 002-30 US
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.).

Study Design


Related Conditions & MeSH terms


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
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