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.
Study Type
OBSERVATIONAL
Enrollment
418
Stanford University
Redwood City, California, United States
NOT_YET_RECRUITINGRush University
Chicago, Illinois, United States
NOT_YET_RECRUITINGNYU Langone
New York, New York, United States
RECRUITINGLiver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (LSM) between iLivTouch-FT9000 and FibroScan 530 devices.
Time frame: 6 months
Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
Time frame: 6 months
To compare the success rate of the iLivTouch and FibroScan
The success rate of examination will be obtained from the percentage of patients who are successful in the test.
Time frame: 6 months
To compare the number of effective examinations of iLivTouch and FibroScan
The number of effective examinations will be obtained from the number of attempts to obtain the effective results.
Time frame: 6 months
Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)
To compare LSM obtained from each device with liver stiffness estimated by APRI. Two liver fibrosis detection results based on LSM and APRI will be compared. The higher values mean more serious fibrosis.
Time frame: 6 months
Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)
Two liver fibrosis detection results based on LSM and FIB-4 will be compared. FIB-4 refers to Age (years), AST Level (U/L), Platelet Count (10\^9/L), ALT (U/L), with higher values mean more serious fibrosis.
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Baylor University
Houston, Texas, United States
NOT_YET_RECRUITINGTime frame: 6 months
Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores
Two liver fibrosis detection results based on LSM and SAFE scores will be compared. The higher values mean more serious fibrosis.
Time frame: 6 months
Adverse events, serious events
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.
Time frame: 6 months