Cardiac Disease
Conditions
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).
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).
Interventions
DIAGNOSTIC_TESTDiagnostic 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.
Sponsors
Sara Guttas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study-level Assessment | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| 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 | o View level acquisition time (minutes and seconds) |
| Patient-Level Acquisition time | 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) |
| View-level Assessment | 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. |
| Comparison of study exam and control exam (View-Level Results) | 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 |
| Comparison of study exam and control exam (Patient-Level Results) | 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 |
| Comparison of study exam and control exam (Task-Based Assessment) | 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 |
| View-Level Acquisition time | 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) |
Countries
United States
Outcome results
None listed