Study for the Assessment of the Quality of Echocardiographic Clips.

NCT ID: NCT05090748

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2022-08-31

Brief Summary

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.

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.

Conditions

Cardiac Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Echocardiographic.

Echocardiographic test.

Intervention Type: DEVICE

Eligibility Criteria

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.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UltraSight

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Lang, MD

Role: PRINCIPAL_INVESTIGATOR

U of Chicago

Federico Asch, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Praveen Mehrotra, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Bijoy Khandheria, MD

Role: PRINCIPAL_INVESTIGATOR

Aurora Saint Luke Medical Center

Robert Klampfner, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Danny Spigelstein, MD

Role: STUDY_DIRECTOR

UltraSight

Locations

University of Chicago Medicine

Chicago, Illinois, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Sheba MC

Ramat Gan, , Israel

Countries

United States; Israel

Other Identifiers

USEG- 201

Identifier Type: -

Identifier Source: org_study_id