Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patient (age >= 18 y.o) followed for a liver disease, all etiologies combined | Experimental | Adult patients followed in the Hepatology or Endocrinology department for a liver disease, suspected chronic liver disease or consequences of chronic liver disease, all etiologies combined. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research FibroScan (FS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduced intra-examination dispersion of liver stiffness measurements with the new measurement method. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bias between the different stiffness measurements (reference/estimated reference/at rest) | Correlation coefficients will be done. | 24 months |
| Bias between the estimated reference stiffness repetitions and between the stiffness at rest repetitions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Llorca | Contact | +33144827850 | anne.llorca@echosens.com | |
| Laura Cantu-Sanchez | Contact | +33144827850 | laura.cantusanchez@echosens.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Nord Essonne - Site Paris- Saclay | Recruiting | Orsay | 91400 | France |
Not provided
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Intra-class correlation coefficients will be done.
| 24 months |
| Bias between the CAP measured with the Research FibroScan and the CAP measured with the Reference FibroScan | Correlation coefficients will be done. | 24 months |
| Bias between the CAP repetitions done with the Research FibroScan | Intra-class correlation coefficients will be done. | 24 months |
| Hôpital Pitié-Salpêtrière | Recruiting | Paris | Île-de-France Region | 75013 | France |
|