Fatty Liver, Liver Fibrosis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEiLivTouch
The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results.
DEVICEFibroScan
The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results.
Sponsors
NYU Langone Health
Stanford University
Rush University
Baylor University
Wuxi Hisky Medical Technology Co Ltd
New Discovery LLC
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians; * b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days; * c. Patients who are willing to participate in the clinical study and can sign ICF.
Exclusion criteria
* a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more; * b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST \>100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) \> 1.8 mg/d (or \>1.5 × ULN =1.2 mg/d); * c. Patients with a history or current evidence of decompensated liver cirrhosis; * d. Patients with various space-occupying tumors and cysts in the right liver; * e. Patients with other serious systemically diseases or a history of malignant tumors; * f. Patients with ascites; * g. Patients with a non-healing wound on the right upper abdomen at this moment; * h. Patients with intracavitary implantation of instruments; * i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening); * j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation); * k. Lack of or limited legal capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection | 6 months | 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. |
| Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI) | 6 months | 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. |
| Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4) | 6 months | 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. |
| To compare the success rate of the iLivTouch and FibroScan | 6 months | The success rate of examination will be obtained from the percentage of patients who are successful in the test. |
| Adverse events, serious events | 6 months | 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. |
| Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores | 6 months | Two liver fibrosis detection results based on LSM and SAFE scores will be compared. The higher values mean more serious fibrosis. |
| To compare the number of effective examinations of iLivTouch and FibroScan | 6 months | The number of effective examinations will be obtained from the number of attempts to obtain the effective results. |
Countries
United States
Contacts
Primary ContactCalvin Q Pan, Dr
Backup ContactHector Ye, PA
Outcome results
None listed