Study for the Assessment of the Quality of Echocardiographic Clips.

NCT05090748 | Completed

• 1 other identifier: USEG- 201
• Study Type: observational
• Target: 240
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cardiac Disease

Outcome Measures

Primary Outcomes (1)

• 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: 1. Sufficient quality to assess Left Ventricular (LV) size: (YES/NO) 2. Sufficient quality to assess LV function: (Yes/No) 3. Sufficient quality to assess Right Ventricular size: (Yes/No) 4. Sufficient quality to assess presence of non-trivial pericardial effusion: (Yes/No)

  1 year.

Secondary Outcomes (2)

• Evaluation of the echo examination quality.

  1 year.

• Evaluation of the echo examination diagnostic quality.

  1 year.

Other Outcomes (1)

• Safety outcome.

  1 year.

Interventions

Echocardiographic. DEVICE

Echocardiographic test.

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UltraSight: lead

Study Sites (3)

University of Chicago Medicine

Chicago, Illinois, 60637,, United States

Location

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215,, United States

Location

Sheba MC

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Danny Spigelstein, MD

  UltraSight

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 25, 2021
• Study Start: May 15, 2022
• Primary Completion: August 5, 2022
• Study Completion: August 31, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); IL (1)