NCT07128108 Multicenter Clinical Study on Noninvasive Assessment of Hepatic Steatosis and Fibrosis Using Visual Transient Elastography
| NCT ID | NCT07128108 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
| Condition | Chronic Liver Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 225 participants |
| Start Date | 2025-08-14 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 225 participants in total. It began in 2025-08-14 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07128108 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Liver Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07128108 currently recruiting?
Yes, NCT07128108 is actively recruiting participants. Contact the research team at csun7682@163.com for enrollment information.
Where is the NCT07128108 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07128108 clinical trial?
NCT07128108 is sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The trial plans to enroll 225 participants.