Condition: Chronic Liver Disease (CLD) · Liver Fibrosis · Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
The goal of this clinical study is to learn whether the Olympus EU-ME3 endoscopic ultrasound shear wave quantification (EUS-SWQ) function can accurately diagnose and grade liver fibrosis in patients with chronic liver disease. It will also learn about the safety and measurement success rate of EUS-SWQ. The main questions it aims to answer are: How closely do EUS-SWQ measurements match liver fibrosis stages determined by liver biopsy (the reference standard)? Does EUS-SWQ correlate better with liver biopsy results than FibroScan? How safe is EUS-SWQ and how often can successful measurements be obtained? Researchers will compare EUS-SWQ results with liver biopsy pathology (METAVIR F0-F4) and with FibroScan results to evaluate its diagnostic value. Participants will: Be adults with chronic liver disease who are scheduled to undergo a clinically indicated liver biopsy Undergo an EUS-SWQ examination as part of the study Have their liver stiffness measured by both EUS-SWQ and FibroScan for comparison Be monitored for any discomfort or adverse events related to the procedures A total of 65 participants will take part in this prospective, single-center, post-market clinical study.
This description comes directly from the study's public registry record.
Baiwen Li, MD · 86-21-37798480 · muzibowen@126.com
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| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07588854