Study for the Assessment of the Quality of Echocardiographic Clips.

Completed

Conditions studied: Cardiac Disease

In brief

This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.

Key facts

Study ID

NCT05090748

Run by

UltraSight

People needed

240

Starts

2022-05-15

Expected to finish

2022-08-31

Last updated by the study team

2022-12-07

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 and older
• Subjects willing and able to give written informed consent.

You may not qualify if…

• Emergency (non-elective) admission within 24 h prior to participating in the study
• Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
• Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
• Subjects who currently participate a clinical trial, involving interventional cardiac devices.
• Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
• Subjects with BMI above 40
• Subjects experiencing a known or suspected acute cardiac event
• Subjects with severe chest wall deformity as per previous medical records and physical examination
• Subjects who have undergone pneumonectomy
• 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.).
• 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.).

Where it is running

• University of Chicago Medicine — Chicago, Illinois, United States
• Aurora St. Luke's Medical Center — Milwaukee, Wisconsin, United States
• Sheba MC — Ramat Gan, Israel

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.