Study of Liver Examination Using a Single Probe FibroScan for Adults with Chronic Liver Disease

What this Trial Is About

This research aims to evaluate the consistency of liver stiffness measurement LSM results obtained using a new Single Probe SP FibroScan device compared to the standard reference probes M and XL in adults with chronic liver diseases. This international, prospective, interventional study includes 309 adult patients from sites in Hong Kong and France. The goal is to assess how well the new single probe performs across various liver disease causes. Participants will undergo FibroScan examinations using different probe setups depending on their group assignment. Early patients 001-050 will have three tests with different single probes followed by a standard examination, with the best single probe selected for subsequent patients. Later groups will receive one or two single probe examinations and one or two standard reference probe exams. The study includes evaluations of test repeatability and patient comfort. During the study, participants will have liver stiffness and controlled attenuation parameter CAP measurements recorded using both the single probe and reference probes. Researchers will compare measurement differences, successful examination rates, and patient comfort scores. The main outcome is the difference in LSM values on the same day. The total study duration extends from November 2025 to May 2027, with primary measurements taken at the initial examination visit.

Development of a FibroScan Liver Examination Using a Single Probe