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OpenTrials
Completed

NCT Number: NCT03887286

Focused Cardiac Ultrasound

To compare the images from standard cardiac ultrasound with images from a small hand-held device; to find out more about the feasibility and accuracy of a small hand-held ultrasound device.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients presenting to pediatric cardiology clinic at Holtz Children's hospital requiring comprehensive or limited transthoracic echocardiogram.
  • Willing and able to provide informed consent or assent.
  • In clinically stable condition as assessed by the principal investigator..
  • With adequate echocardiographic windows.

Exclusion criteria

  • Patients with poor echocardiographic windows.
  • Patients who refuse informed consent.
  • Pregnant women.
  • Prisoners.
  • Patients deemed unfit to participate in the clinical trial as assessed by the principal investigator.

Treatment and study plan

Philips EPIQ 7 ultrasound machine

Device

Standard transthoracic echocardiography

Philips Lumify Broadband sector array transducer

Device

Portable hand-held ultrasound device

Primary outcomes

  1. Number of Patients Detected With Ventricular Dysfunction, Pericardial Effusion, Valvular Disorders, Septal Disorders, and Coronary Anomalies.

    Time frame: Day 1

    Comparison of diagnostic ability of portable hand-held cardiac ultrasound with standard transthoracic echocardiography

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Feasibility and Accuracy of Focused Cardiac Ultrasound Using an FDA Approved Hand-held Ultrasound Device in Outpatient Setting in Our Institution.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 22, 2019
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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