[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633725":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":10,"centralContacts":37,"locations":45,"responsibleParty":56,"collaborators":10,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":10,"enrollmentInfo":71,"targetDuration":74,"studyType":75,"phases":10,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":90,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Seoul National University Hospital","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A: Healthy Reference (Living-donor candidates)",null,"Adult living-donor candidates undergoing donor evaluation at SNUH. Confirmed hepatic steatosis \\\u003C5%, normal AST\u002FALT, and absence of chronic liver disease. Participation does not affect donor candidacy decisions.",[13,14],"Device: Samsung Medison HERA W12 (R30) with S-Shearwave platform","Device: Canon Aplio i800 with Dispersion Slope Imaging",{"label":16,"type":10,"description":17,"interventionNames":18},"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 \\\u003C6.82 kPa AND DeepUSFF \\\u003C7.86% (\\\u003CS1) AND AST ≤40 U\u002FL (institutional ULN).",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"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\u002FL. Participants meeting neither Cohort B nor Cohort C definitions are classified as 'Indeterminate' and analyzed as an exploratory subgroup.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"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 \\\u003C15.05%), or those meeting only a subset of the Cohort B\u002FC 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.",[13,14],[28,33],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"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 %).",[9,16,20,24],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"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\u002Fs\\]\u002FkHz, viscosity-related).",[9,16,20,24],[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Jeong Min Lee, MD, PhD","CONTACT","+82-2-2072-3154","jmlshy2000@gmail.com",{"name":44,"role":40,"phone":10,"phoneExt":10,"email":10},"Jeong Hwan Park, MD",[46],{"facility":5,"status":10,"city":47,"state":10,"zip":48,"country":49,"countryCode":10,"cosmosGeoPoint":50,"geoPoint":55,"contacts":10},"Seoul","03080","South Korea",{"type":51,"coordinates":52},"Point",[53,54],126.9784,37.566,{"lat":54,"lon":53},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Jeong Min Lee","Professor","100633725","samsung-s-viscosity-vs-canon-dispersion-slope-in-steatotic-liver-disease-savid-sld-100633725",false,"NCT07530419","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","SAVID-SLD","Inclusion Criteria:\n\n* \\[Cohort A - Healthy reference\\]\n\n  * Adults ≥18 years old\n  * Currently undergoing living-donor evaluation at SNUH\n  * Donor evaluation confirms (a) hepatic steatosis \\\u003C5% by imaging or biopsy, (b) normal AST\u002FALT, and (c) absence of chronic liver disease (HBV, HCV, autoimmune, cholestatic, etc.)\n  * Provided written informed consent \\[Cohort B + C - Steatotic liver disease\\]\n  * Adults ≥18 years old\n  * Sonographically suspected or confirmed hepatic steatosis on B-mode ultrasound, scheduled for clinical abdominal ultrasound\n  * Serum AST\u002FALT results available within 6 weeks of ultrasound, or scheduled\n  * Provided written informed consent\n\nExclusion Criteria:\n\n* • Significant alcohol intake within the past 2 years (\\>30-60 g\u002Fday for males, \\>20-50 g\u002Fday for females)\n\n  * Diagnosed or strongly suspected chronic liver disease (active HBV\u002FHCV, autoimmune liver disease, cholestatic liver disease, Wilson's disease, hemochromatosis, etc.)\n  * Suspected hepatic failure or decompensated cirrhosis (albumin \\\u003C3.2 g\u002FdL, INR \\>1.3, direct bilirubin \\>1.3 mg\u002FdL)\n  * Ascites, history of variceal bleeding, or acute biliary obstruction rendering stable measurements unfeasible\n  * History of liver malignancy or treatment for liver malignancy\n  * History of liver surgery\n  * Pregnancy or lactation\n  * Inadequate ultrasound image quality due to obesity, bowel gas, or patient inability to cooperate",true,"ALL","18 Years",{"count":72,"type":73},95,"ESTIMATED","1 Week","OBSERVATIONAL","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.\n\nThis 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.",[78,79,80],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Fatty Liver","Liver Fibrosis",[82,83,84,85,86,87,88,89],"Shear wave elastography","Viscoelasticity","Dispersion slope","Liver stiffness","Quantitative ultrasound","MASLD","MASH","S-Viscosity","NOT_YET_RECRUITING","2026-04-08",{"date":93,"type":94},"2026-04-15","ACTUAL",{"date":96,"type":73},"2026-04-10",{"date":98,"type":73},"2027-02-28",{"name":5,"class":6},1]