Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 210
- 主要终点
- Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
研究概览
简要总结
The aims of this study are to assess the performance of the non-invasive Electrical Impedance Technology (EIT) in evaluating the liver fibrosis stage in patients with chronic liver diseases, in comparisons with a liver biopsy and/or Shear wave elastography and Liver Ultrasonography.
The second aim is comparing between Liver Ultrasonography and Electrical Impedance Technology (EIT) to quantify the hepatic steatosis grade in patients with Non Alcoholic Fatty Liver Disease (NAFLD) .
详细描述
The study will include 210 patients with chronic liver diseases. Relevant clinical data such as sex, age, weight, height, alcohol intake, medical history and routine lab results will be collected.
The study will include three groups:
- Patients with indication for liver biopsy will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).
- Patients with chronic liver diseases will undergo routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).
- Patients with Non Alcoholic Fatty Liver Disease will undergo routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT) (70 patients).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic liver diseases
排除标准
- •Patients who don't have chronic liver diseases
研究组 & 干预措施
Biopsy: Routine tests & EIT Technology
The patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
干预措施: EIT Technology (Device)
Routine tests & EIT Technology
The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
干预措施: EIT Technology (Device)
NASH : Routine tests & EIT Technology
The patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT).
干预措施: EIT Technology (Device)
结局指标
主要结局
Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
时间窗: Each technology will be performed once in 1 year
Comparing EIT fibrosis stage result to fibrosis stage result of validated thechnologies
次要结局
未报告次要终点
研究者
Prof. Ziv Ben-Ari MD
Head of liver diseases center
Sheba Medical Center