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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults and pediatric patients, all etiologies combined | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research FibroScan | Device | After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done:
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jérôme Boursier, Pr | University Hospital, Angers | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Amiens | Amiens | France | ||||
| CHU d'Angers |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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|
| 7 months |
| Angers |
| France |
| CHU de Lille | Lille | France |
| Hôpital Saint Eloi | Montpellier | France |
| CHU de Nancy | Nancy | France |
| CHU de Nice | Nice | France |
| D013568 |
| Pathological Conditions, Signs and Symptoms |