An interventional study of TransThoracic Echocardiography imaging in Cardiac Disease, Heart Failure and Cardiac Ischemia, sponsored by Philips Healthcare. Completed at 1 site in France. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-03.
Sponsored by Philips Healthcare · Not applicable, Interventional, and Diagnostic
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.
The primary objective of this study is to assess the feasibility for non-expert users (medical professionals but non-certified sonographers) to acquire parasternal, apical and subcostal views of suitable quality by using an existing ultrasound device (CE-marked, available in the market) and an additional guidance system (software prototype + probe motion tracking device). Such a system will help the user to place the probe on the patient and provide guidance for optimal acquisition of parasternal, apical and subcostal views.
The secondary objective of this study is to assess the feasibility for non-expert users to reproduce a simple clinical protocol by using an existing ultrasound device and the same additional guidance system.
Exclusion Criteria:
Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors
Device: TransThoracic Echocardiography imaging
Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors
Device: TransThoracic Echocardiography imaging
ultrasound scanning
Echocardiography acquisition score [in %] [Operator's outcome]
Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score
Time frame: Day 1
Time to acquisition [in seconds] [Operator's performance]
Time to acquisition \[in seconds\] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Time frame: Day 1
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]
Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition \[Reproducibility of the probe position and orientation\]
Time frame: Day 1
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]
Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition \[Geometrical reliability of the probe position and orientation\]
Time frame: Day 1
Left ventricular Ejection Fraction [in %] [Measurement reproducibility]
Left ventricular Ejection Fraction \[in %\] by Simpson's biplane method
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Philips Healthcare