Heart Failure Clinical Trial
— EPISODEOfficial title:
Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
Verified date | February 2021 |
Source | Philips Healthcare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU Caen Service de Cardiologie | Caen |
Lead Sponsor | Collaborator |
---|---|
Philips Healthcare |
France,
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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