Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)

NCT07530419 · tracked via the Priya Life Science South Korea tracker

Sponsor

Seoul National University Hospital

Phase

Observational

Started

2026-04-10

Last updated

2026-04-15

Condition(s) studied

Metabolic Dysfunction-Associated Steatotic Liver DiseaseFatty LiverLiver Fibrosis

Investigational drug(s) / intervention(s)

Samsung Medison HERA W12 (R30) with S-Shearwave platformCanon Aplio i800 with Dispersion Slope Imaging

Samsung Medison HERA W12 (R30) with S-Shearwave platform: Two-dimensional shear-wave elastography acquisition with the Samsung HERA W12 R30 system using the CA 1-7S convex probe. Five valid measurements per parameter are obtained from the right hepatic lobe via right intercostal approach, repeated in 2 sessions. Output parameters include S-Viscosity (dispersion-derived viscosity index), 2D S-SWE (liver stiffness in kPa), TAI (tissue attenuation imaging), and DeepUSFF (deep-learning-based ultrasound fat fraction in %).

Canon Aplio i800 with Dispersion Slope Imaging: Two-dimensional shear-wave elastography and Dispersion Slope Imaging acquisition with the Canon Aplio i800 system using the i8C1 convex probe. Five valid measurements are obtained from the right hepatic lobe via right intercostal approach. Output parameters include 2D SWE (liver stiffness in kPa) and Dispersion Slope (in \[m/s\]/kHz, viscosity-related).

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * \[Cohort A - Healthy reference\] * 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 Exclusion Criteria: * • 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

Primary outcome measure(s)

Correlation between Samsung S-Viscosity and Canon Dispersion Slope — At the time of single study visit (Day 0)
Pearson or Spearman correlation coefficient (with 95% CI) between Samsung S-Viscosity and Canon Dispersion Slope, calculated from the median of 5 valid measurements per device per participant.
Inter-vendor agreement (Bland-Altman analysis) — At the time of single study visit (Day 0)
Mean bias and 95% limits of agreement between Samsung S-Viscosity and Canon Dispersion Slope calculated by Bland-Altman analysis. As the two parameters use different units, agreement will also be assessed after z-score transformation

Trial sites (1)

Facility	City	Region	Status
Seoul National University Hospital	Seoul	South Korea

More Seoul National University Hospital trials in South Korea

Lung Cancer Surgery in Sarcopenia Patients With Old Age Active, not recruiting

Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION) Recruiting

Radioembolization as a Spearhead Treatment of Hepatocellular Carcinoma With Localized Portal Vein Tumor Thrombosis Recruiting

Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Recruiting

Reduction of Remifentanil-related Complications Starting soon

Other trials for the same condition

A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes) Recruiting

Quantitative Ultrasound(DeepUSFF) vs MRI-PDFF for Liver Fat Assessment in MASLD Recruiting

Korean Health Screening-Based Metabolic Dysfunction-Associated Steatotic Liver Disease Registry Starting soon

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis Recruiting

Pioglitazone and Empagliflozin for Fatty Liver Disease in Type 2 Diabetes Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07530419 on ClinicalTrials.gov ↗ ← All trials in South Korea