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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2021-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cardiac Disease Heart Failure Cardiac Ischemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Masking is not applicable, since software study

Study Groups

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Scanned patients

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

Group Type EXPERIMENTAL

TransThoracic Echocardiography imaging

Intervention Type DEVICE

ultrasound scanning

Non-expert scanning volunteers

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

Group Type EXPERIMENTAL

TransThoracic Echocardiography imaging

Intervention Type DEVICE

ultrasound scanning

Interventions

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TransThoracic Echocardiography imaging

ultrasound scanning

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes