SHAPE:SeeingtheHeartwithAIPoweredEcho

Cardiac Disease Clinical Trial

— SHAPE  

Official title:

SHAPE: Seeing the Heart With AI Powered Echo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705650
• Other study ID #: SHAPE01
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: September 6, 2019

Study information

• Verified date: March 2020
• Source: Caption Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 6, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Patients indicated for a standard physical examination

2. Patients =65 years old

For patients in Phase I, one of the following additional inclusion criteria must be present:

1. Patient presenting with a new murmur, or history of a murmur but no prior echo within 3 years of the exam

2. Patient presenting with shortness of breath

3. Unexplained pedal edema

Exclusion Criteria:

1. Unable to lie flat for study

2. Significant anatomical abnormality, recent trauma, or recent thoracic/abdominal surgery that would limit the ability to obtain adequate images

3. Subjects unwilling or unable to give written informed consent

4. 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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Memorial, Central DuPage	Winfield	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Sara Guttas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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	Number of minutes for non-specialists to perform studies using EchoGPS experimental guidance software	Number of minutes for non-specialists to perform studies using EchoGPS software as compared to that of the time for expert sonographer's control studies using FDA 510(k)-cleared, commercially available ultrasound platform. The time of Study Exam will be compared to that of Control Exam on a per subject basis (paired difference) for Phase I of the study.	1 year