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Point-of-Care Echocardiography With Assistance Technology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03897140
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Sara Guttas, Caption Health, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Cardiac Disease Diagnostic Test: Diagnostic Test: Limited Echocardiogram Not Applicable

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study for Point-of-Care Echocardiography With Assistance Technology
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : May 23, 2019
Actual Study Completion Date : May 23, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients scheduled for an echocardiogram
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Study-level Assessment [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]

    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.



Secondary Outcome Measures :
  1. View-level Assessment [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    The Outcome Measure will be reported as the percentage of patient studies with diagnostic quality clip for a particular Standard View acquired in the study. 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.

  2. Inter-User Variability (Primary Clinical Parameters) [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o Comparison of user variability for primary clinical parameters (measured as the coefficient variation for binary assessment of whether the study is of diagnostic quality to make a particular clinical assessment)

  3. Inter-User Variability (Acquisition Time) [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o View level acquisition time (minutes and seconds)

  4. Patient-Level Acquisition time [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o Patient level acquisition time (minutes and seconds)

  5. View-Level Acquisition time [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o View-level acquisition time (minutes and seconds)

  6. Comparison of study exam and control exam (View-Level Results) [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o Comparison of View level results measured as percent agreement of images with diagnostic quality

  7. Comparison of study exam and control exam (Patient-Level Results) [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o Comparison of patient level results measured as percent agreement of patient exams of sufficient quality to make a particular clinical assessment

  8. Comparison of study exam and control exam (Task-Based Assessment) [ Time Frame: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments ]
    o Comparison of qualitative assessments from study and control exam to assess whether cardiologists reach a similar decision with study exam images and control exam images


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All patients must meet the following inclusion criteria to participate in the study:

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

Exclusion Criteria:

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897140


Locations
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United States, Illinois
Northwestern Medicine, Bluhm Cardiovascular Institute
Chicago, Illinois, United States, 60611
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Sara Guttas
Investigators
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Principal Investigator: Akhil Narang, MD Northwestern Medicine, Bluhm Cardiovascular Institute
More Information
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Responsible Party: Sara Guttas, Clinical Applications Manager, Caption Health, Inc.
ClinicalTrials.gov Identifier: NCT03897140    
Other Study ID Numbers: EchoGPSPivotal1.0
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) will not be made available to other researchers.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases