Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

Human Factors Validation Study of Artificial Intelligence Ultrasound Navigation Software for Cardiac Imaging

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05660044

Enrollment

Registered

2022-12-21

Start date

2022-07-20

Completion date

2022-08-03

Last updated

2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Brief summary

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

Detailed 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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Usability of UltraSight AI guidance software	10 days	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

Countries

Israel

Outcome results