NCT07530419Active, not recruiting
Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)
Prospective Evaluation of Samsung Medison 2D Shear Wave Elastography Viscoelasticity Parameters in Patients With Steatotic Liver Disease Using Canon Dispersion Slope Imaging as Reference Standard: A Single-Center Non-Interventional Observational Study
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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 R20 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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 95 (estimated)
- First submitted
- 8 Apr 2026
- Start date
- 24 Apr 2026
- Primary completion date
- 7 Oct 2026
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07530419
What you commit to
- Study type: Observational
- Planned participants: 95
- From 24 Apr 2026 to the primary completion date, 7 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- • 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
Who the study is looking for
- \[Cohort A - Healthy reference\]
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.