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

NCT07530419 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2026-04-15

No results posted yet for this 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.

Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Fatty Liver
  • Liver Fibrosis

Interventions

DEVICE

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 %).

DEVICE

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).

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2026-12-30
Completion
2027-02-28

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07530419 on ClinicalTrials.gov