Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity

Study Overview
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Brief Summary
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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) .

Detailed Description
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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).

Official Title
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Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity

Conditions
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Chronic Liver Disease, Fibrosis, Liver, Non-Alcoholic Fatty Liver Disease

Intervention / Treatment
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* Device: EIT Technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic liver diseases Exclusion Criteria: Patients who don't have chronic liver diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biopsy: Routine tests & EIT Technology<br>The patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT). | Device: EIT Technology<br>* Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage<br>|
| Experimental: Routine tests & EIT Technology<br>The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT). | Device: EIT Technology<br>* Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage<br>|
| Experimental: NASH : Routine tests & EIT Technology<br>The patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT). | Device: EIT Technology<br>* Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT) | Comparing EIT fibrosis stage result to fibrosis stage result of validated thechnologies | Each technology will be performed once in 1 year |