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

Not Applicable

• Conditions: Fibrosis, Liver; Chronic Liver Disease; Non-Alcoholic Fatty Liver Disease
• Interventions: Device: EIT Technology

• Registration Number: NCT03492879
• Lead Sponsor: Prof. Ziv Ben-Ari MD

Brief Summary

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

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:

1. 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).

2. Patients with chronic liver diseases will undergo routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT) (70 patients).

3. 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).

Study Timeline

• Status Verified: 2018-04
• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-04-03
• Last Update Submitted: 2018-04-03
• Study First Posted: 2018-04-10
• Last Update Posted: 2018-04-10
• Study Start: 2018-05-15
• Primary Completion: 2019-05-15
• Study Completion: 2019-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

Inclusion Criteria

• Patients with chronic liver diseases

Exclusion Criteria

• Patients who don't have chronic liver diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biopsy: Routine tests & EIT Technology	EIT Technology	The patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
Routine tests & EIT Technology	EIT Technology	The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
NASH : Routine tests & EIT Technology	EIT Technology	The patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT).

Primary Outcome Measures

Name	Time	Method
Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)	Each technology will be performed once in 1 year	Comparing EIT fibrosis stage result to fibrosis stage result of validated thechnologies