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FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Wuxi Hisky Medical Technology Co Ltd · 2014
ClinicalTrials.gov · Datasets · License: Public Domain · 2014
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chronic-hepatitis-bcirrhosisliver-fibrosis
This prospective and multicenter study is to determine the diagnostic performance (accuracy, specificity and sensitivity) of transient elastography (FibroTouch) for liver fibrosis assessment in chronic hepatitis B (CHB) patients using ROC analysis, and liver biopsy as the reference. Actual 517 patients will be enrolled to guarantee 500 final statistical cases; and ≥100 cases are required for fibrosis stage S0/1, S2, S3 and S4 (compensatory stage of cirrhosis), respectively. For each stage, the case is assigned as equally as possible.
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