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SHAPE:SeeingtheHeartwithAIPoweredEcho

NCT03705650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-03-23

No results posted yet for this study

Summary

Establish transthoracic echocardiogram (TTE) exams performed with Bay Labs EchoGPS guidance technology can be used in a primary care setting to accurately identify cardiac disease. In Phase I TTE exams with EchoGPS will be compared to findings from a commercially available, FDA 510(k)-cleared reference device (Terason uSmart 3200t, point-of-care ultrasound) without EchoGPS assistance technology. Study is non-significant risk (NSR).

Conditions

  • Cardiac Disease

Interventions

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 and interpretation assistance to users during image acquisition. For this study, CMAs will use EchoGPS to perform point-of-care echocardiogram examinations.

Sponsors & Collaborators

  • Sara Guttas

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-10
Primary Completion
2019-03-30
Completion
2019-09-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03705650 on ClinicalTrials.gov