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

Study Overview
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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.

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

Conditions
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Liver Fibrosis

Intervention / Treatment
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* Device: Research FibroScan


Participation Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults and pediatric patients, all etiologies combined<br> | Device: Research FibroScan<br>* After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done: Standard examination [Reference CE-marked FibroScan]: the operator will need to find an optimal measurement area, and perform 10 valid measurements. 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. 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The bias between the CAPc measured with the VCTE (Reference FibroScan) and the CAPc measured by the Vibration Guided Transient Elastography (VGTE) (Research FibroScan). |  | 7 months | 
| Calculate the bias between the PCD measured by the VCTE (Reference FibroScan) and the PCD measured by the VGTE (Research FibroScan). |  | 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Stiffness Measurement, VCTE, FibroScan, Vibration Control Transient Elastography, Vibration Guided Transient Elastography, VGTE