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

Echosens200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

200

Conditions

Liver Fibrosis

Interventions

Research FibroScanDEVICE

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).

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (6)

CHU d'Amiens

Amiens, France

CHU d'Angers

Angers, France

CHU de Lille

Lille, France

Hôpital Saint Eloi

Montpellier, France

CHU de Nancy

Nancy, France

Outcomes

Primary Outcomes

Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan)

The validity criteria is an analysis of the measurement, automatically computed by the FibroScan. A measurement analyzed as "valid" leads to a reliable LSM whereas a measurement analyzed as "invalid" leads to a non-reliable LSM.

Time frame: 7 months

Secondary Outcomes

The bias between the CAPc measured with the VCTE (Reference FibroScan) and the CAPc measured by the Vibration Guided Transient Elastography (VGTE) (Research FibroScan).

Time frame: 7 months

Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan).

Time frame: 7 months

Data from ClinicalTrials.gov

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