Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
225 participants
Aug 14, 2025
OBSERVATIONAL
Conditions
Summary
Using liver biopsy as the gold standard, this study will conduct visual transient elastography (ViTE) examinations using Mindray Hepatus 9 ultrasound diagnostic system in patients with liver injury to evaluate the diagnostic efficacy of Liver Steatosis Analysis (LiSA) and ViTE for grading hepatic steatosis and fibrosis, and establish corresponding diagnostic thresholds.
Eligibility
Inclusion Criteria3
- Be aged 18-65 years.
- Documented liver injury of any etiology with a liver biopsy performed within the past 2 weeks.
- Willing to undergo Visual Transient Elastography (ViTE) examination using Mindray Hepatus 9 Ultrasound System and capable of providing written informed consent.
Exclusion Criteria5
- Acute viral hepatitis.
- Right heart failure with either:Serum transaminases >5× upper limit of normal (ULN),Total bilirubin >85.5 μmol/L.
- History of hepatocellular carcinoma (HCC).
- Pregnancy.
- Patients with implantable medical devices.
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Interventions
Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07128108