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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03642730
Other study ID # ICBE-2-11984
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date January 1, 2021

Study information

Verified date February 2021
Source Philips Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date January 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - All volunteers must have the ability to provide informed consent. - All volunteers should be affiliated to the French Social Security. - All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care. Exclusion Criteria: - Subjects with congenital heart diseases (except bicuspid aortic valve) - Pregnant women - Adults lacking decisional capacity - Adults placed under a legal protection regime (guardianship, curatorship, judicial protection) - Adults not affiliated to the French Social Security - Adults in emergent or critical condition - Adults with active pain in the intended scanning region - Adults with active skin disease or lesions in the intended scanning region - Adults with allergy/sensitivity to ultrasound gel

Study Design


Intervention

Device:
TransThoracic Echocardiography imaging
ultrasound scanning

Locations

Country Name City State
France CHU Caen Service de Cardiologie Caen

Sponsors (1)

Lead Sponsor Collaborator
Philips Healthcare

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Primary 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% Day 1
Primary 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] Day 1
Primary 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] Day 1
Secondary Left ventricular Ejection Fraction [in %] [Measurement reproducibility] Left ventricular Ejection Fraction [in %] by Simpson's biplane method Day 1
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