SHAPE:SeeingtheHeartwithAIPoweredEcho

NCT03705650 | Completed FDA Device

• 1 other identifier: SHAPE01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Disease detection; Medicare aged patients; routine physical examination; primary care; limited echocardiogram

Outcome Measures

Primary Outcomes (1)

• % of diagnostic quality clips acquired by a non-specialist using experimental guidance software, with quality assessed using the American College of Emergency Physician (ACEP) Suggested Quality Assurance Grading Scale

  All of the echo views (or "clips") acquired by non-specialists during the study will be scored for image quality (IQ) by clinicians using the 1-5 ACEP quality grading scale. In this scale, a score of 1 represents the poorest IQ and 5 the highest. Images must have a score of 3 or higher to be considered diagnostic quality. Diagnostic quality images (3+) meet at least minimal criteria for diagnosis to be supported and are therefore clinically acceptable.

  1 year

Secondary Outcomes (1)

• Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software

  1 year

Study Arms (1)

Medicare Primary Care Provider (PCP) Patients

EXPERIMENTAL

This is a non-randomized study of non-significant risk (NSR) that will be conducted at Northwestern's Central Dupage Hospital. Medicare patients \> 65 years who are scheduled for a routine physical exam with their PCP that meet inclusion and exclusion criteria will be asked to participate in this study. Consenting patients will be scheduled for 2 back to back ultrasound scans including 5 standard 2D echocardiogram views each. The first scan will be performed by a non-ultrasound specialist using EchoGPS experimental guidance technology and the second control exam will be performed by a trained sonographer using a cleared conventional ultrasound platform.

Diagnostic Test: Limited Echocardiogram

Interventions

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

Medicare Primary Care Provider (PCP) Patients

Eligibility Criteria

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

You may qualify if:

• Patients indicated for a standard physical examination
• Patients ≥65 years old
• Patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam
• Patient presenting with shortness of breath
• Unexplained pedal edema

You may not qualify if:

• Unable to lie flat for study
• Significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images
• Subjects unwilling or unable to give written informed consent
• Patients experiencing a known or suspected acute cardiac event Eligibility criteria for Phases II and III of this study will be finalized once results from Phase I are available. The current plan is to have similar criteria for Phases II and III.

Sponsors & Collaborators

• Sara Guttas: lead

Study Sites (1)

Northwestern Memorial, Central DuPage

Winfield, Illinois, 60190, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

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 at Bay Labs

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: October 10, 2018
• Primary Completion: March 30, 2019
• Study Completion: September 6, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

US (1)