Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)
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Conditions studied: Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver, Liver Fibrosis
In brief
Steatotic liver disease (SLD) is one of the most common chronic liver diseases worldwide. Distinguishing simple steatosis from metabolic dysfunction-associated steatohepatitis (MASH) with significant fibrosis is clinically important, but liver biopsy - the current standard - is invasive. Recent ultrasound technology allows noninvasive measurement of tissue viscoelasticity, which has been linked to liver inflammation. Samsung Medison's HERA W12 system (S-Viscosity) and Canon Aplio i800 (Dispersion Slope Imaging) both provide vendor-specific viscoelasticity parameters derived from shear-wave dispersion analysis, but their relationship and agreement have not been compared in SLD patients. This prospective single-center observational study will enroll approximately 95-100 participants in three cohorts: (A) 15-20 living-donor candidates as a healthy reference, (B+C) approximately 80 adults with sonographically suspected or confirmed SLD recruited consecutively. SLD participants will be classified post-hoc into low-MASH-risk (Cohort B) and at-risk MASH (Cohort C) subgroups using a multi-parametric stratification combining liver stiffness (LSM), DeepUSFF (deep-learning-based ultrasound fat fraction), and serum AST. All participants will undergo same-day ultrasound examination with both Samsung HERA W12 and Canon Aplio i800. The primary objective is to evaluate the correlation and agreement between Samsung S-Viscosity and Canon Dispersion Slope. Secondary objectives include deriving a normal reference range from the healthy cohort, comparing viscoelasticity parameters across cohorts, and exploring a Modified US-FAST score.
Key facts
- Study ID
- NCT07530419
- Run by
- Seoul National University Hospital
- People needed
- 95
- Starts
- 2026-04-10
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- [Cohort A - Healthy reference]
- Adults ≥18 years old
- Currently undergoing living-donor evaluation at SNUH
- Donor evaluation confirms (a) hepatic steatosis <5% by imaging or biopsy, (b) normal AST/ALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)
- Provided written informed consent [Cohort B + C - Steatotic liver disease]
- Adults ≥18 years old
- Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound
- Serum AST/ALT results available within 6 weeks of ultrasound, or scheduled
- Provided written informed consent
You may not qualify if…
- • Significant alcohol intake within the past 2 years (>30-60 g/day for males, >20-50 g/day for females)
- Diagnosed or strongly suspected chronic liver disease (active HBV/HCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)
- Suspected hepatic failure or decompensated cirrhosis (albumin <3.2 g/dL, INR >1.3, direct bilirubin >1.3 mg/dL)
- Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible
- History of liver malignancy or treatment for liver malignancy
- History of liver surgery
- Pregnancy or lactation
- Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate
Where it is running
- Seoul National University Hospital — Seoul, South Korea
Full record on ClinicalTrials.gov
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