Study for the Assessment of the Quality of Echocardiographic Clips.

A Pivotal Study for the Assessment of the Quality of Echocardiographic Clips When Obtained by Novice Users While Using the UltraSight Echocardiography Guidance (USEG) Software.

This study main objective is to evaluate the safety and efficacy of the UltraSight AI Guidance software. The investigational product is a software that guides the user to capture a high quality ultrasound image. The study will include healthcare professionals, not specialized in echocardiography, who will perform echocardiography by using UltraSight AI Guidance software, on subjects in the medical centers cardiac units.

Study Overview

• Status: Completed
• Conditions: Cardiac Disease
• Intervention / Treatment: Device: Echocardiographic.

Detailed Description

This pivotal study is a multi-center, multi-reader multi-case (MRMC) study, designed to assess the quality of the clips obtained by novice users when using the UltraSight AI Guidance software. Prior to the study start, there will be a pre-study training phase for training the novice users.

During the study, eligible subject will undergo the echocardiography examination twice on a single study visit (same day): once by one of the novice users when using the UltraSight AI Guidance software, and once by an expert sonographer without the aid of the software.

Each novice user will perform the examination on at least 20 subjects (with the aim that the number of examinations by each novice will be similar). All examinations will be sent to multiple Board certified cardiologists for their quality evaluations.

• Study Type: Observational
• Enrollment (Actual): 240

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel
    • Sheba MC
• United States
  • Illinois
    • Chicago, Illinois, United States, 60637,
      • University of Chicago Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215,
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

male and female adults confirmed as eligible according to eligibility criteria.

Description

Inclusion Criteria:

1. Age 18 and older
2. Subjects willing and able to give written informed consent.

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will perform a urine pregnancy test)
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
6. Subjects with BMI above 40
7. Subjects experiencing a known or suspected acute cardiac event
8. Subjects with severe chest wall deformity as per previous medical records and physical examination
9. Subjects who have undergone pneumonectomy

10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).

    • A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.).

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the echo examination sufficiency.	The expert cardiologists will evaluate whether the echo examination quality obtained by novice users has sufficient to evaluate each of the primary endpoints: Sufficient quality to assess Left Ventricular (LV) size: (YES/NO); Sufficient quality to assess LV function: (Yes/No); Sufficient quality to assess Right Ventricular size: (Yes/No); Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)	1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the echo examination quality.	The expert cardiologists will evaluate whether the echo examination performed by novice users has sufficient quality to evaluate the following six (6) anatomic elements: Qualitative visual assessment of RV function: (Yes/No); Qualitative visual assessment of left atrium size: (Yes/No); Qualitative visual assessment of Aortic valve structure: (Yes/No); Qualitative visual assessment of Mitral valve structure: (Yes/No); Qualitative visual assessment of Tricuspid valve structure: (Yes/No); Qualitative visual assessment of IVC size: (Yes/No)	1 year.
Evaluation of the echo examination diagnostic quality.	The expert cardiologists will evaluate if each of the following 10 views taken by novice users can be considered of diagnostic quality: Apical 4 chamber; Apical 2 chamber; Apical 3 chamber; Apical 5 chamber; Para Sternal Long Axis; Para Sternal short axis - Aortic Valve (AV); Para Sternal short axis - Mitral Valve (MV); Para Sternal short axis - Papillary Muscle (PM); Sub Costal - 4 chamber; Sub Costal - Inferior Vena Cava (IVC) In order to assess intra-cardiologist variability, a repeated assessment of the expert cardiologist analysis will be done in 10% of the exams.	1 year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome.	Adverse events.	1 year.

Collaborators and Investigators

• Sponsor: UltraSight
• Investigators: Principal Investigator: Roberto Lang, MD, U of Chicago; Principal Investigator: Federico Asch, MD, Medstar Health Research Institute; Principal Investigator: Praveen Mehrotra, MD, Thomas Jefferson University; Principal Investigator: Bijoy Khandheria, MD, Aurora Saint Luke Medical Center; Principal Investigator: Robert Klampfner, MD, Sheba Medical Center; Study Director: Danny Spigelstein, MD, UltraSight

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): August 5, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: October 11, 2021
• First Submitted That Met QC Criteria: October 11, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: USEG- 201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No