Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT07128108

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

Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-11-24

225

Participants Needed

1

Research Sites

124 weeks

Total Duration

On this page

Sponsors

X

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Lead Sponsor

S

Shenzhen Mindray Bio-Medical Electronics Co., Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be aged 18-65 years.
  • Have documented liver injury of any cause with a liver biopsy performed within the past 2 weeks.
  • Be willing to undergo Visual Transient Elastography (ViTE) examination using the Mindray Hepatus 9 Ultrasound System.
  • Be able to provide written informed consent.
Not Eligible

You will not qualify if you...

  • Acute viral hepatitis.
  • Right heart failure with serum transaminases greater than 5 times the upper limit of normal or total bilirubin over 85.5 µmol/L.
  • History of hepatocellular carcinoma (liver cancer).
  • Pregnancy.
  • Presence of implantable medical devices.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200082

Actively Recruiting

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Research Team

C

Chao Sun, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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