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Automated Ultrasound Cardiac Guidance Tool

Sponsor
UltraSight (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05649826
Collaborator
(none)
200
Enrollment
1
Location
51.9
Anticipated Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Optimization of an Ultrasound Cardiac Guidance Tool
    Anticipated Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    May 1, 2027
    Anticipated Study Completion Date :
    May 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Acquisition of transthoracic echocardiography media from up to 200 subjects [up to 5 year]

      Several echocardiography views will be acquired from the participants, with in several acoustic windows and views

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Males and females, aged 18 years and older

    2. Subject 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 provide a statement that they are not pregnant incorporated in the ICF

    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 in 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.).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wayne University Detroit Michigan United States 48201

    Sponsors and Collaborators

    • UltraSight

    Investigators

    • Principal Investigator: Robert Ehrman, MD, Wayne University Emergency medicine
    • Study Director: Noa Avisar, PhD, UltraSight

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UltraSight
    ClinicalTrials.gov Identifier:
    NCT05649826
    Other Study ID Numbers:
    • 002-30 US
    First Posted:
    Dec 14, 2022
    Last Update Posted:
    Dec 14, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 14, 2022