Point-of-Care Echocardiography With Assistance Technology

NCT03897140 | Completed FDA Device

• 1 other identifier: EchoGPSPivotal1.0
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• Study-level Assessment

  The primary endpoints for the study are separate patient-level assessments of whether the patient study is of adequate image quality to make a qualitative visual assessment for a particular clinical parameter (ie., Yes/No). Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer. The Outcome Measure will be reported as the percentage of patient studies for which the panel of cardiologist readers adjudicated as being of sufficient image quality to make a particular clinical assessment.

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Secondary Outcomes (8)

• View-level Assessment

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

• Inter-User Variability (Primary Clinical Parameters)

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

• Inter-User Variability (Acquisition Time)

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

• Patient-Level Acquisition time

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

• View-Level Acquisition time

  Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments

Study Arms (1)

Patients scheduled for an echocardiogram

EXPERIMENTAL

Patients ≥18 years scheduled for an echocardiographic examination. This is a non-randomized, un-blinded, study in patients with an indication for an echocardiographic examination. Enrolled patients will be stratified into two groups based on known cardiac abnormalities to ensure a sufficient number of patients with cardiac abnormalities and into 3 strata of BMI: normal, overweight and obese.

Diagnostic Test: Diagnostic Test: Limited Echocardiogram

Interventions

Diagnostic Test: Limited Echocardiogram DIAGNOSTIC_TEST

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.

Patients scheduled for an echocardiogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for an echocardiographic examination
• Patients ≥18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Sara Guttas: lead

Study Sites (2)

Northwestern Medicine, Bluhm Cardiovascular Institute

Chicago, Illinois, 60611, United States

Location

Minneapolis Heart Institute

Minneapolis, Minnesota, 55407, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Akhil Narang, MD

  Northwestern Medicine, Bluhm Cardiovascular Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Applications Manager

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: April 1, 2019
• Study Start: March 25, 2019
• Primary Completion: May 23, 2019
• Study Completion: May 23, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: N/A - IPD will not be made available to other researchers.
• Access Criteria: N/A - IPD will not be made available to other researchers.

Locations

US (2)