Liver Diseases
Conditions
Keywords
FibroScan, Vibration Controlled Transient Elastography, Liver Stiffness Measurement
Brief summary
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 153 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.
Interventions
DEVICEResearch FibroScan (FS)
Patients #1 to #25: Exam 1: Examination with Research FibroScan. Exam 2: Examination with the Reference FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #26 to #75: Exam 1: Examination with the Research or Reference FibroScan. Exam 2: Examination with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exam 1. Patients #76 to #114: Exams 1 \& 2: 2 consecutive examinations with the Research or Reference FibroScan. Exams 3 \& 4: 2 consecutive examinations with the Reference or Research FibroScan at the same measurement point and with the same probe used for the Exams 1 \& 2.
Sponsors
Echosens
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined. * Adult patient able to give his written consent * Patient affiliated to the French Social Security system
Exclusion criteria
* Vulnerable patients * Patients with liver ascites * Patients with heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method. | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bias between the different stiffness measurements (reference/estimated reference/at rest) | 24 months | Correlation coefficients will be done. |
| Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions. | 24 months | Intra-class correlation coefficients will be done. |
| Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan | 24 months | Correlation coefficients will be done. |
| Bias between the CAP repetitions done with the Research FibroScan | 24 months | Intra-class correlation coefficients will be done. |
Countries
France
Contacts
CONTACTAnne Llorca
CONTACTLaura Cantu-Sanchez
Outcome results
None listed