Metabolic Dysfunction-Associated Steatotic Liver DiseaseSAVID-SLDNCT07530419
Samsung S-Viscosity vs Canon Dispersion Slope in Steatotic Liver Disease (SAVID-SLD)
An observational study of Metabolic Dysfunction-Associated Steatotic Liver Disease and Fatty Liver, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver, Liver Fibrosis
- What is being tested?
- Samsung Medison HERA W12 (R30) with S-Shearwave platform and Canon Aplio i800 with Dispersion Slope Imaging
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Apr 2026to 30 Dec 2027
- How long will I take part?
- 1 Week
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 years or older recruited from Seoul National University Hospital, including (1) living-donor candidates undergoing donor evaluation as a healthy reference cohort, and (2) outpatients with sonographically suspected or confirmed hepatic steatosis scheduled for clinical abdominal ultrasound.
Who may be able to join
- [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
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- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Background: Two-dimensional shear wave elastography (2D SWE) is widely used to quantify liver stiffness for fibrosis assessment, but stiffness can be confounded by inflammation, congestion, and other factors. Frequency-dependent shear-wave dispersion analysis yields viscosity-related parameters that may reflect tissue inflammation. Canon's Dispersion Slope Imaging (DS, [m/s]/kHz) has been validated against histology in the multicenter iLEAD study (Sugimoto et al., Radiology 2024) and shown to correlate with lobular inflammation in MASLD. Samsung Medison has recently introduced S-Viscosity within the S-Shearwave platform of the HERA W12 R30 system, providing dispersion-derived viscosity parameters from a single SWE acquisition; however, head-to-head comparison with Canon DS in SLD patients has not been reported.
Hypothesis: Samsung S-Viscosity and Canon Dispersion Slope, both derived from frequency-dependent shear-wave analysis, will demonstrate moderate-to-strong correlation and clinically acceptable inter-vendor agreement in patients with steatotic liver disease.
Study Design: Single-center, prospective, non-interventional observational study. Adult participants (≥18 years) will be enrolled into three cohorts: Cohort A (Healthy reference, n=15-20): living-donor candidates with confirmed steatosis <5%, normal LFTs, and exclusion of chronic liver disease, recruited during routine donor evaluation. Cohort B+C (SLD, n≈80): adults with sonographically suspected or confirmed hepatic steatosis scheduled for clinical abdominal ultrasound, recruited consecutively. Post-hoc stratification of SLD participants uses LSM (2D S-SWE), DeepUSFF, and serum AST with institutionally-validated cutoffs (LSM 6.82 kPa for ≥F2 fibrosis; DeepUSFF asymmetric cutoffs of 7.86% for <S1 rule-out and 15.05% for ≥S2 rule-in; AST 40 U/L institutional ULN) to define Low MASH risk (Cohort B), At-risk MASH (Cohort C), and an Indeterminate zone.
Procedures: All participants undergo same-day ultrasound examinations on both Samsung HERA W12 (CA 1-7S probe) and Canon Aplio i800 (i8C1 probe) in randomized order, with operators blinded to LFT results at the time of scanning. From the right hepatic lobe via right intercostal approach after a minimum 4-hour fast: Samsung acquisitions include 2D S-Viscosity, 2D S-SWE, TAI, and DeepUSFF (5 measurements per parameter, 2 sessions); Canon acquisitions include Dispersion Slope Imaging and 2D SWE (5 measurements). Median values are used as representative.
Statistical Analysis: Primary endpoints - Pearson or Spearman correlation between Samsung S-Viscosity and Canon Dispersion Slope (with 95% CI), and Bland-Altman analysis of inter-vendor agreement (mean bias and 95% limits of agreement). Sample size of approximately 80 SLD participants provides adequate precision for both correlation (r=0.4 to 0.6) and Bland-Altman limits-of-agreement estimation (±0.5 SD precision). Secondary endpoints include 95% reference interval derivation from Cohort A (n≥15 for nonparametric estimation), inter-cohort comparisons, Modified US-FAST score exploration, reproducibility (ICC and CV%), and technical success rate.
- Being tested
- Samsung Medison HERA W12 (R30) with S-Shearwave platform, Canon Aplio i800 with Dispersion Slope Imaging
- Keywords
- Shear wave elastography, Viscoelasticity, Dispersion slope, Liver stiffness, Quantitative ultrasound, MASLD, MASH, S-Viscosity
- Medical subject headings
- Fatty Liver, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Samsung Medison HERA W12 (R30) with S-Shearwave platformDevice
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 ImagingDevice
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 group | Role | What they receive |
|---|---|---|
| Cohort A: Healthy Reference (Living-donor candidates) | Adult living-donor candidates undergoing donor evaluation at SNUH. Confirmed hepatic steatosis <5%, normal AST/ALT, and absence of chronic liver disease. Participation does not affect donor candidacy decisions. Receives: Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Device: Canon Aplio i800 with Dispersion Slope Imaging | |
| Cohort B: Low MASH Risk MASLD (Rule-out) | Adults with sonographically suspected or confirmed hepatic steatosis classified post-hoc as low MASH risk by satisfying ALL three criteria: LSM <6.82 kPa AND DeepUSFF <7.86% (<S1) AND AST ≤40 U/L (institutional ULN). Receives: Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Device: Canon Aplio i800 with Dispersion Slope Imaging | |
| Cohort C: At-Risk MASH MASLD (Rule-in) | Adults with sonographically suspected or confirmed hepatic steatosis classified post-hoc as at-risk MASH by satisfying mandatory LSM ≥6.82 kPa (suggestive of ≥F2 significant fibrosis) AND at least one of: DeepUSFF ≥15.05% (≥S2) OR AST >40 U/L. Participants meeting neither Cohort B nor Cohort C definitions are classified as 'Indeterminate' and analyzed as an exploratory subgroup. Receives: Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Device: Canon Aplio i800 with Dispersion Slope Imaging | |
| Cohort D: Indeterminate Zone (Exploratory subgroup) | Adults with sonographically suspected or confirmed hepatic steatosis who do not meet the full criteria for either Cohort B (Low MASH risk) or Cohort C (At-risk MASH). This cohort primarily includes participants with DeepUSFF values in the S1 range (7.86% to <15.05%), or those meeting only a subset of the Cohort B/C criteria. Cohort D is analyzed as a pre-specified exploratory subgroup and is not included in the primary stratified comparison between Cohort B and Cohort C. Descriptive statistics are reported separately. Receives: Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform; Device: Canon Aplio i800 with Dispersion Slope Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Samsung S-Viscosity and Canon Dispersion Slope
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.
Measured: At the time of single study visit (Day 0)
Inter-vendor agreement (Bland-Altman analysis)
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
Measured: At the time of single study visit (Day 0)
Secondary outcomes (5)
Normal reference range of viscoelasticity parameters
95% reference interval (2.5-97.5 percentile) of Samsung S-Viscosity and Canon Dispersion Slope estimated nonparametrically from Cohort A (healthy reference cohort).
Measured: At the time of single study visit (Day 0)
Inter-cohort comparison of viscoelasticity parameters
Difference in Samsung S-Viscosity and Canon Dispersion Slope between Cohort B (Low MASH risk) and Cohort C (At-risk MASH), tested by t-test or Mann-Whitney U.
Measured: At the time of single study visit (Day 0)
Modified US-FAST score performance (exploratory)
AUROC of a Modified US-FAST score - calculated by substituting Samsung 2D S-SWE LSM and DeepUSFF into the LSM and CAP positions of the original FAST score formula (Newsome et al., Lancet Gastroenterol Hepatol 2020) - for identifying Cohort C participants. Correlation with Canon Dispersion Slope is also assessed.
Measured: At the time of single study visit (Day 0)
Reproducibility of viscoelasticity measurements
Intraclass correlation coefficient (ICC, 2-way random effects) and coefficient of variation (CV%) of repeated viscoelasticity measurements across two acquisition sessions per device.
Measured: At the time of single study visit (Day 0)
Technical success rate
Proportion of participants in whom valid viscoelasticity measurements were successfully obtained on both devices (Samsung HERA W12 and Canon Aplio i800).
Measured: At the time of single study visit (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start24 Apr 2026
- Primary completion7 Oct 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Min Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07530419
- Sponsor's protocol ID
- SNUH-RAD-SWE-Visco-2026-V1.2
- Other IDs
- SNUH IRB: 2601-153-1712
- Acronym
- SAVID-SLD
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sugimoto K, et al. US Markers and Necroinflammation, Steatosis, and Fibrosis in Metabolic Dysfunction-associated Steatotic Liver Disease: The iLEAD Study. Radiology. 2024;312(2):e233377. Newsome PN, et al. FibroScan-AST (FAST) score for the non-invasive identification of patients with non-alcoholic steatohepatitis with significant activity and fibrosis: a prospective derivation and global validation study. Lancet Gastroenterol Hepatol. 2020;5(4):362-373. Barr RG, et al. Update to the Society of Radiologists in Ultrasound Liver Elastography Consensus Statement. Radiology. 2020;296(2):263-274. WFUMB Guidelines/Guidance on Liver Multiparametric Ultrasound. Ultrasound Med Biol. 2024;50(8):1088-1098.