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Development of Predictive Indicators of Homogeneous Propagation of Ultrasound and Elastic Waves During VCTE Examination

NCT ID: NCT04747457

Last Updated: 2021-10-13

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-06

Study Completion Date

2021-09-29

Brief Summary

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This is an European, prospective, interventional, and multicenter exploratory clinical investigation that will take place in 6 French sites and 200 patients will be included (adults and children). The study objective is to develop predictive indicators of homogeneous propagation of ultrasound and elastic waves to define an optimal region of interest for the measurement of liver stiffness during VCTE examination.

Detailed Description

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Conditions

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Liver Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Adults and pediatric patients, all etiologies combined

Group Type EXPERIMENTAL

Research FibroScan

Intervention Type DEVICE

After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done:

1. Standard examination \[Reference CE-marked FibroScan\]: the operator will need to find an optimal measurement area, and perform 10 valid measurements.
2. Standard examination \[Research FibroScan\]: the operator must take 15 valid measurements at the same measurement point as the one used for the examination with the Reference FibroScan.
3. Exploratory examination \[Research FibroScan\]: the operator needs to perform15 invalid measurements to acquire data in non-optimal regions of measurement (lungs, vessels, intestines, ribs, edges of the liver).

Interventions

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Research FibroScan

After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done:

1. Standard examination \[Reference CE-marked FibroScan\]: the operator will need to find an optimal measurement area, and perform 10 valid measurements.
2. Standard examination \[Research FibroScan\]: the operator must take 15 valid measurements at the same measurement point as the one used for the examination with the Reference FibroScan.
3. Exploratory examination \[Research FibroScan\]: the operator needs to perform15 invalid measurements to acquire data in non-optimal regions of measurement (lungs, vessels, intestines, ribs, edges of the liver).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult and pediatric patients, all etiologies combined
* Patient must be able to give written informed consent, or the parents in the case of a minor patient
* Patient affiliated to a social security system

Exclusion Criteria

* Vulnerable patient- other than pediatric patients
* Pregnant or breastfeeding woman
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Echosens

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jérôme Boursier, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Angers

Locations

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CHU d'Amiens

Amiens, , France

Site Status

CHU d'Angers

Angers, , France

Site Status

CHU de Lille

Lille, , France

Site Status

Hôpital Saint Eloi

Montpellier, , France

Site Status

CHU de Nancy

Nancy, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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M138

Identifier Type: -

Identifier Source: org_study_id