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

Last updated: August 15, 2025
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Visual Transient Elastography (ViTE) Examination

Clinical Study ID

NCT07128108
Hepatus-V1
  • Ages 18-65
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Be aged 18-65 years.

  • Documented liver injury of any etiology with a liver biopsy performed within thepast 2 weeks.

  • Willing to undergo Visual Transient Elastography (ViTE) examination using MindrayHepatus 9 Ultrasound System and capable of providing written informed consent.

Exclusion

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.

Study Design

Total Participants: 225
Treatment Group(s): 1
Primary Treatment: Visual Transient Elastography (ViTE) Examination
Phase:
Study Start date:
August 01, 2025
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200082
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.