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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Visual Transient Elastography (ViTE) Examination

Treatment groups

No treatment groups listed

Sponsors and collaborators

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Lead sponsor

Shenzhen Mindray Bio-Medical Electronics Co., Ltd

Collaborator