NCT03897140

Point-of-Care Echocardiography With Assistance Technology

Study for Point-of-Care Echocardiography With Assistance Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Sara Guttas · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

Detailed description

To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).

Conditions

• Cardiac Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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 to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations.

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-05-23
• Completion: 2019-05-23
• First posted: 2019-04-01
• Last updated: 2019-09-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study