Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

UltraSight

Status: Completed

Conditions: Cardiac Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT05660044

USEG 301

Details and patient eligibility

About

The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.

Full description

Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.

Enrollment: 34 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 18 and older
• Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
• Have the capacity to understand study risks and consent to be in the study
• Be available and willing to participate in the study
• Not be employed by the Sponsor or another medical device or pharmaceutical company

Exclusion criteria