XinHua Hospital Affiliated To Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200082, China
Location status: Recruiting
Recruiting
NCT Number: NCT07128108
Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography
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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Visual Transient Elastography (ViTE) Examination
OtherPost-marketing product (Mindray Hepatus 9 Ultrasound Diagnostic System) for visual transient elastography examination in patients with liver injury.
Primary outcomes
-
The diagnostic performance of LiSA and ViTE was evaluated using the area under the receiver operating characteristic curve (AUROC).
Time frame: baseline
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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Other
Collaborators
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Aug 17, 2025
- Registry last updated
- Nov 24, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.