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
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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RECRUITING
225 participants
OBSERVATIONAL
2025-08-14
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Shenzhen Mindray Bio-Medical Electronics Co., Ltd
UNKNOWN
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Locations
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XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hepatus-V1
Identifier Type: -
Identifier Source: org_study_id
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