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

NCT07128108 | Recruiting

• 1 other identifier: Hepatus-V1
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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

Mindray Hepatus 9 Ultrasound Diagnostic System; Chronic Liver Injury

Outcome Measures

Primary Outcomes (1)

• The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).

  Optimal cutoff values for LiSA and ViTE were determined by maximizing the Youden index, sensitivity (Se), and specificity (Sp). For each cutoff value, the following metrics with 95% confidence intervals (CI) were calculated: sensitivity (Se), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV).

  baseline

Interventions

Visual Transient Elastography (ViTE) Examination OTHER

Post-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with liver injury

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shenzhen Mindray Bio-Medical Electronics Co., Ltd: collaborator

Study Sites (1)

XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200082, China

RECRUITING

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Central Study Contacts

Chao Sun, PhD

CONTACT

08613818676775; csun7682@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)