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Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging (EPISODE)

Primary Purpose

Cardiac Disease, Heart Failure, Cardiac Ischemia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TransThoracic Echocardiography imaging
Sponsored by
Philips Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cardiac Disease focused on measuring echocardiography, training, follow-up

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Caen Service de Cardiologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Scanned patients

Non-expert scanning volunteers

Arm Description

Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors

Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors

Outcomes

Primary Outcome Measures

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 to acquisition [in seconds] [Operator's performance]
Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
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]
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]

Secondary Outcome Measures

Left ventricular Ejection Fraction [in %] [Measurement reproducibility]
Left ventricular Ejection Fraction [in %] by Simpson's biplane method

Full Information

First Posted
May 9, 2018
Last Updated
February 2, 2021
Sponsor
Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT03642730
Brief Title
Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
Acronym
EPISODE
Official Title
Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Heart Failure, Cardiac Ischemia
Keywords
echocardiography, training, follow-up

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Masking is not applicable, since software study
Allocation
Non-Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scanned patients
Arm Type
Experimental
Arm Description
Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors
Arm Title
Non-expert scanning volunteers
Arm Type
Experimental
Arm Description
Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors
Intervention Type
Device
Intervention Name(s)
TransThoracic Echocardiography imaging
Intervention Description
ultrasound scanning
Primary Outcome Measure Information:
Title
Echocardiography acquisition score [in %] [Operator's outcome]
Description
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
Title
Time to acquisition [in seconds] [Operator's performance]
Description
Time to acquisition [in seconds] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%
Time Frame
Day 1
Title
Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]
Description
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
Title
Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]
Description
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
Secondary Outcome Measure Information:
Title
Left ventricular Ejection Fraction [in %] [Measurement reproducibility]
Description
Left ventricular Ejection Fraction [in %] by Simpson's biplane method
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Saloux, MD
Organizational Affiliation
Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Caen Service de Cardiologie
City
Caen
ZIP/Postal Code
14033
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Interactive Guided Ultrasound Examinations Done by Non-experts of Ultrasound Imaging

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