NCT03705650

SHAPE:SeeingtheHeartwithAIPoweredEcho

SHAPE: Seeing the Heart With AI Powered Echo

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Sara Guttas · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

Establish transthoracic echocardiogram (TTE) exams performed with Bay Labs EchoGPS guidance technology can be used in a primary care setting to accurately identify cardiac disease. In Phase I TTE exams with EchoGPS will be compared to findings from a commercially available, FDA 510(k)-cleared reference device (Terason uSmart 3200t, point-of-care ultrasound) without EchoGPS assistance technology. Study is non-significant risk (NSR).

Conditions

• Cardiac Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Limited Echocardiogram	STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance, feedback and interpretation assistance to users during image acquisition. For this study, CMAs will use EchoGPS to perform point-of-care echocardiogram examinations.

Timeline

• Start date: 2018-10-10
• Primary completion: 2019-03-30
• Completion: 2019-09-06
• First posted: 2018-10-15
• Last updated: 2020-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study