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临床试验/NCT06802731
NCT06802731招募中不适用

A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease

Wuxi Hisky Medical Technology Co Ltd1 个研究点 分布在 1 个国家目标入组 365 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
365
试验地点
1
主要终点
Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.

研究概览

简要总结

To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.

详细描述

This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
  • Age over 18 years old, gender not limited;
  • Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
  • Perform iLivTouch examination within ± 14 days of liver pathology examination;
  • No history of excessive alcohol consumption (converted to ethanol:<140g/week for males,<70g/week for females);

排除标准

  • 未提供

结局指标

主要结局

Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.

时间窗: 12 months

次要结局

未报告次要终点

研究者

发起方
Wuxi Hisky Medical Technology Co Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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