Study for the Assessment of USEG Software.

Launched by ULTRASIGHT · Sep 23, 2021

Keywords

ClinConnect Summary

Study Design:

This pilot study is a single center, multi-reader multi-case study, primarily designed to obtain the quality of the echocardiography exam, obtained by novice users when using the USEG software.

Eligible subject will undergo the examination twice on a single study visit : once by one of novice users when using the USEG software and once by one of the expert sonographers without the aid of the software.

Each novice user will perform the examination on approximately 30 subjects (depending on the number of novice user, with the aim that the number of examinations by each novice...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 and older
• • 2. Subjects 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 (WOCBP\* will perform a urine pregnancy test)
• • 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 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 echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, etc.)
• • A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.)