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

NCT ID: NCT07128108

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-14

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Liver Injury Mindray Hepatus 9 Ultrasound Diagnostic System

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Visual Transient Elastography (ViTE) Examination

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Mindray Bio-Medical Electronics Co., Ltd

UNKNOWN

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chao Sun, PhD

Role: CONTACT

08613818676775

Facility Contacts

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Chao Sun, PhD

Role: primary

13651751329

Other Identifiers

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Hepatus-V1

Identifier Type: -

Identifier Source: org_study_id

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