Menu
Recruiting NCT07128108

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

— Observational Chronic Liver Injury Mindray Hepatus 9 Ultrasound Diagnostic System

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Visual Transient Elastography (ViTE) Examination.
Who it may be relevant to
Registry conditions: Chronic Liver Injury, Mindray Hepatus 9 Ultrasound Diagnostic System. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC). [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07128108 · Hepatus-V1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗