Validation of the New Vibration-guided FibroScan Examination

Study Overview
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Brief Summary
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This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 100 adults patients will be included. The study objective is to compare the applicability between the Research FibroScan and the reference FibroScan examination performed on the liver.

Detailed Description
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Chronic liver disease (CLD) is a silent disease that can progress to life-threatening conditions. Hepatitis B (HBV) and C (HCV) viruses, alcoholic liver disease (ALD) and non-alcoholic fatty liver disease (NAFLD) are the main causes of chronic liver inflammation. CLDs represent a major public health burden, with global estimates showing around a rate of 2 million deaths per year, including 1 million from complications of cirrhosis and 1 million from viral hepatitis and hepatocellular carcinoma. About 75 million people are diagnosed with alcohol use disorders and are at risk of developing alcohol-related liver disease. About 2 billion adults are obese or overweight and more than 400 million suffer from diabetes; both of which are risk factors for the development of NAFLD and HCC. NAFLD is currently the leading cause of CLD worldwide with a reported worldwide prevalence of 25% in adults. Early identification among NAFLD patients with non-alcoholic steatohepatatis (NASH) and advanced fibrosis is particularly important as they are at high risk of developing liver complications. The main difficulty in diagnosing NASH patients is related to their symptomatology, which is not always clinically useful because it is not specific. Therefore a screening for advanced stage of NAFLD is recommended in patient at high risk such patients with type 2 diabetes or obesity. Liver fibrosis is known to be a major prognostic predictor of hepatic and overall mortality in patients with CLD. Therefore, early diagnosis of liver fibrosis is crucial in asymptomatic individuals. Liver biopsy (LB) is the gold standard diagnostic test for the evaluation of patients with CLD. However, it is difficult to use it as a screening tool given the large number of patients with NAFLD. The development of non-invasive and broadly applicable screening tools for the assessment of liver fibrosis appears to be a major public health opportunity. Among the non-invasive tools available, the FibroScan (Echosens™, Paris, France) has proven to be a useful tool for diagnosing fibrosis and steatosis in patients with CLD. FibroScan is a device based on Vibration-Controlled Transient Elastography (VCTE™) technology that measures Liver Stiffness Elasticity (LSM) to assess fibrosis and Controlled Attenuation Parameter (CAP) to assess steatosis. In this context, Echosens aims to develop a new technology called Vibration-Guided Transient Elastography (VGTE) which is an original method that will help FibroScan operators to localize an optimal region of interest for stiffness measurement in a simple and reliable way.

Official Title
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Validation of the New Vibration-guided FibroScan Examination

Conditions
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Liver Diseases

Intervention / Treatment
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* Device: Research FibroScan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (age > 18 years old) followed for a liver disease; all etiologies combined Patient must be able to give written informed consent Patient affiliated to a social security system Exclusion Criteria: Vulnerable patient Patients with ascites

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Adult patient (age > 18 y.o) followed for a liver disease, all etiologies combined<br>Adult patients followed in the Hepatology or Endocrinology department for a liver disease, all etiologies combined. | Device: Research FibroScan<br>* Once the inclusion and exclusion criteria are validated, the investigator can propose the study to the patient. After taking the time needed to consider the study, the patient will decide if he/she wants to participate in the study and to sign off the informed consent form. The following examinations will be performed for each patient using the probe as per recommendations displayed on the screen. The same probe must be used for examinations. Patients #1 to #70: Exam 1: Exploratory exam with the Research FibroScan and the M+ or XL+ probe. Exam 2: Reference exam with the CE-marked FibroScan and the M+ or XL+ probe. Patients #71 to #100: Exams 1 and 2: Two consecutive exploratory exams with the Research FibroScan and the M+ or XL+ probe. Exams 3 and 4: two consecutive reference exams with the CE-marked FibroScan and the M+ or XL+ probe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of patient percentage having a successful examination between the novel and the reference FibroScan examination | To compare the applicability between the novel FibroScan and the reference FibroScan examination performed on the liver | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of success rate between the novel and the reference FibroScan examination | To compare the success rate between the novel and the reference FibroScan examination | 9 months | 
| Difference between the initial localization durations required for the novel and the reference FibroScan examination. | To compare, between the novel and the reference examination, the duration of the initial localization, defined between the time the operator places the probe on the patient and the time needed to obtain the first valid stiffness measurement | 9 months | 
| Difference between the examination durations required for the novel and the reference examination based on liver stiffness measurements. | To compare between the novel and the reference examination the duration between the time of the operator places the probe on the patient and the time he obtains 10 valid liver stiffness measurements | 9 months | 
| Difference between the examination durations required for the novel and the reference examination based on CAP measurements. | To compare between the novel and the reference examination, the duration between the time of the operator places the probe on the patient and the time he obtains the CAP value with the gauge at 100%. | 9 months | 
| Intraclass Correlation Coefficient (ICC) between novel and reference FibroScan examinations | To compare the agreement of CAP, stiffness and skin to capsule distance (SCD) between the novel and the reference examination | 9 months | 
| Evaluation of the operator perception between the novel and reference examination | To compare with a dedicated questionnaire (quantitative scale), the operator perception related to the probe vibration, indicator display and easy of use. | 9 months | 
| Evaluation of the patient perception between the novel and reference examination | To compare with a dedicated questionnaire (quantitative scale), the patient perception related to the probe vibration | 9 months | 
| Intraclass Correlation Coefficient (ICC) between novel and reference FibroScan examinations and coefficient of variability of stiffness and CAP examination performed by the same operator, on the same patient on the same day (two procedures in a row). | To evaluate the repeatability (same day, same operator) of the stiffness and the CAP measurements of the novel and the reference examinations | 9 months | 

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