Human Factors Study of Ultrasound Navigation Software for Cardiac Imaging
Completed
- Conditions
- Cardiac Disease
- Registration Number
- NCT05660044
- Lead Sponsor
- UltraSight
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sheba medical center
🇮🇱Ramat Gan, Israel