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NCT05660044 Clinical Trial

Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

Cardiac Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05660044
Other study ID # USEG 301
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 20, 2022
Est. completion date August 3, 2022

Study information
Verified date June 2022
Source UltraSight
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date August 3, 2022
Est. primary completion date August 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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: -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba medical center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
UltraSight

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 10 days
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