NCT07128108

Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 225 (estimated)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Liver Injury
• Mindray Hepatus 9 Ultrasound Diagnostic System

Interventions

Type	Name	Description
OTHER	Visual Transient Elastography (ViTE) Examination	Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.

Timeline

• Start date: 2025-08-14
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-08-17
• Last updated: 2025-11-24

Locations

1 site across 1 country: China