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

Study acronym: SAVID-SLD
StatusActive, Not Recruiting
PhaseNot specified
Started

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Record History

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  1. Minor Trial status changed: Not Yet Recruiting → Active, Not Recruiting Show 7 more changesShow less
    • Primary completion moved earlier from Dec 30, 2026 to Oct 7, 2026
    • Study completion pushed from Feb 28, 2027 to Dec 30, 2027
    • Start date changed from estimate of Apr 10, 2026 to Apr 24, 2026
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 1 of 5 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
  2. Minor Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07530419
Lead Sponsor Seoul National University Hospital
Conditions
(from sponsor)
Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver, Liver Fibrosis
Related terms Fatty Liver, Liver Cirrhosis
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov