Liver Fibrosis
Conditions
Keywords
FibroScan, Vibration Control Transient Elastography, Vibration Guided Transient Elastography, Liver Stiffness Measurement, VCTE, VGTE
Brief summary
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.
Interventions
DEVICEResearch 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).
Sponsors
Echosens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validity criteria of the Liver Stiffness Measurement (LSM) by Vibration Controlled Transient Elastography (VCTE) (automatically assessed by the Reference and the Research FibroScan) | 7 months | 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. |
Secondary
| Measure | 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 |
Countries
France
Outcome results
None listed