Point-of-Care Echocardiography With Assistance Technology

Completed · Not applicable

Conditions studied: Cardiac Disease

In brief

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).

Key facts

Study ID

NCT03897140

Run by

Sara Guttas

People needed

240

Starts

2019-03-25

Expected to finish

2019-05-23

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All patients must meet the following inclusion criteria to participate in the study:
• Patients scheduled for an echocardiographic examination
• Patients ≥18 years old

You may not qualify if…

• Patients must NOT meet any of the following exclusion criteria to participate in the trial:
• Unable to lie flat for study
• Patients experiencing a known or suspected acute cardiac event
• Patients with severe chest wall abnormalities
• Patients who have undergone pneumonectomy
• Patients unwilling or unable to give written informed consent

Where it is running

• Northwestern Medicine, Bluhm Cardiovascular Institute — Chicago, Illinois, United States
• Minneapolis Heart Institute — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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