Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-20

Study Completion Date

2022-08-03

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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