Fatty Liver Clinical Trial
Official title:
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.
Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA Objectives: 1. Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices. 2. Secondary Objectives 1. To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations. 2. To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores. 3. The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal. ;
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