FibroTouch Non-invasive Evaluation of Liver Fibrosis and Cirrhosis

Launched by WUXI HISKY MEDICAL TECHNOLOGY CO LTD · Jun 16, 2015

Keywords

ClinConnect Summary

The liver diseases frequently occur in China. For various reasons, the chronic liver diseases are not controlled in time, and then develop gradually into liver fibrosis and cirrhosis. Without effective treatment, the advanced liver cirrhosis seriously influences the quality of patients' life, and places an intolerable burden on family and society. At present, the scholars generally thought that the liver fibrosis at early stages is reversible. Therefore, if the liver fibrosis in patients with chronic liver diseases can be accurately evaluated at early stages and be treated in time, so we ca...

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Eligibility criteria

• Inclusion Criteria:
• • Subjects with age 18-65 years, both gender
• • Subjects with history of HBV or HBsAg positive \> 6 months up to enrollment
• • Subjects with qualified liver biopsy specimens within three months (before or after) of Fibrotouch examination for pathological staging
• • Subjects without chemical therapy history of powerful medicine to lower enzyme in the two weeks before blood biochemistry tests (e.g. dimethyl diphenyl bicarboxylate and bicyclol)
• • Subjects must agree and sign the informed consent form
• Exclusion Criteria:
• • Subjects who are unable or unwilling to sign informed consent form
• • Subjects who have merger of hepatitis C, alcohol and non-alcoholic fatty liver diseases, autoimmune liver diseases, inherited metabolic liver diseases, biliary systemic diseases or liver and gall parasitic diseases
• • Subjects who have other serious chronic disorders or history of malignancy
• • Subjects with ALT ≥5 ULN in the past 1 month
• • Subjects with WBC\<3.5×10\^9/L, PLT\<60×10\^9/L, PTA\<60%
• • Subjects with DBIL≥1.5 ULN
• • Subjects with decompensated cirrhosis (especially the people with ascites)
• • Pregnant or lactating women, or women who has a pregnant plan and don't want to birth control in the study period
• • Subjects who have wound on the right upper abdomen recently
• • Subjects who have various space-occupying tumor or cyst in right liver
• • Subjects who have none or limited legal capacity