Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

UltraSight34 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cardiac Disease

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (1)

Sheba medical center

Ramat Gan, Israel

Outcomes

Primary Outcomes

Usability of UltraSight AI guidance software

Demonstrate that the Product can be used by the intended users by a questionnaire that is filled by an observation moderator which will assess the ease of use and user satisfaction

Time frame: 10 days

Data from ClinicalTrials.gov

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