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NCT Number: NCT05649826

Automated Ultrasound Cardiac Guidance Tool

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

Recruiting

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Key information

Conditions

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Wayne University

Detroit, Michigan, 48201, United States

Location status: Recruiting

Location contact

Laura Gowland, sonographer

CONTACT

[email protected]

313-577-1268

Robert Ehrman, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Males and females, aged 18 years and older
  • Subject willing and able to give written informed consent

Exclusion criteria

  • Emergency (non-elective) admission within 24 h prior to participating in the study
  • Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
  • Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
  • Subjects who currently participate in 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.).

Treatment and study plan

Primary outcomes

  1. Acquisition of transthoracic echocardiography media from up to 200 subjects

    Time frame: up to 5 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Gowland, Sonographer

CONTACT

[email protected]

313-5771268

Robert Ehrman, MD

CONTACT

[email protected]

313-5771268

Sponsors and collaborators

Lead sponsor

UltraSight

Industry

Registry information

Official study title

Optimization of an Ultrasound Cardiac Guidance Tool

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 14, 2022
Registry last updated
May 21, 2024

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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