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OpenTrials
Completed

NCT Number: NCT05660044

Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging

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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Key information

Conditions

Cardiac Disease Cardiovascular Diseases Heart Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sheba medical center

Ramat Gan, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Usability of UltraSight AI guidance software

    Time frame: 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

Sponsors and collaborators

Lead sponsor

UltraSight

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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