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OpenTrials
Completed

NCT Number: NCT04981444

Optimization of an Automated Ultrasound Cardiac Guidance Tool

Open-label, single-arm, prospective study. Subjects will undergo one session of 2D Transthoracic Echocardiogram (2D-TTE) ultrasound. The ultrasound will be performed by a trained sonographer.

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Key information

Conditions

Ultrasound Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

The study will use a commercially available handheld imaging device (Philips Lumify transducer).

Primary Objective:

To acquire images of multiple transducer position, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe positions.

Who can participate

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

Inclusion criteria

  • Age 18 years and above.
  • Patients able to understand, read and sign the informed consent
  • Patient willing to answer a short questionnaire

Exclusion criteria

  • Pregnancy(females of childbearing potential will be tested with a urine pregnancy test prior to their inclusion in the study)
  • Not willing or not able to sign an inform consent
  • Physical limitation to maneuvering the probe on the body
  • Unable to lie flat for study
  • Patients experiencing a known or suspected acute cardiac event
  • Patients with severe chest wall abnormalities
  • Patients who have undergone pneumonectomy
  • Patients whose anatomy does not lend itself to echocardiography

Treatment and study plan

Primary outcomes

  1. ACCURACY- Optimization of an automated ultrasound cardiac guidance tool.

    Time frame: 1 year

    To acquire images from different transducer positions, trajectories, and views, at different acoustic windows for capturing images and location relative to body and probe.

    This study is designed to capture data for the training of the UltraSight Guidance software AI models. The obtained data will not be anlyzed for statistical purposes but will only be used for the algorithm development based on the technician movements recording, with no reference to images quality or medical utilization.

Sponsors and collaborators

Lead sponsor

UltraSight

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jul 29, 2021
Registry last updated
Nov 14, 2022

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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