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| Name | Class |
|---|---|
| NYU Langone Health | OTHER |
| Stanford University | OTHER |
| Rush University | OTHER |
| Baylor University |
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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:
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.
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iLivTouch then FibroScan | Subjects in the Group "iLivTouch then FibroScan" will be measured using iLivTouch first and then FibroScan based on the randomization result. |
| |
| FibroScan then iLivTouch | Subjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iLivTouch | Device | The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Liver 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. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| To compare the number of effective examinations of iLivTouch and FibroScan |
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Inclusion Criteria:
Exclusion Criteria:
Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians
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The following conditions are considered as patient withdrawal from the current study:
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Calvin Q Pan, Dr | Contact | (718) 888-7728 | Panc01@nyu.edu | |
| Hector Ye, PA | Contact | 17188880518 | hector.ye.pa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Calvin Q. Pan | NYU Langone Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Not yet recruiting | Redwood City | California | 94305 | United States |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| OTHER |
| Wuxi Hisky Medical Technology Co Ltd | INDUSTRY |
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| FibroScan | Device | The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results. |
|
The number of effective examinations will be obtained from the number of attempts to obtain the effective results. |
| 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. | 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. | 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. | 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. | 6 months |
| Rush University | Not yet recruiting | Chicago | Illinois | 60612 | United States |
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| NYU Langone | Recruiting | New York | New York | 11355 | United States |
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| Baylor University | Not yet recruiting | Houston | Texas | 76798 | United States |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |