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

Overview

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) .

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 15, 2019

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).

Interventions

  • Device: EIT Technology
    • Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage

Arms, Groups and Cohorts

  • Experimental: 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).
  • Experimental: Routine tests & EIT Technology
    • The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
  • Experimental: 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).

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with chronic liver diseases Exclusion Criteria:

  • Patients who don't have chronic liver diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Prof. Ziv Ben-Ari MD
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Prof. Ziv Ben-Ari MD, Head of liver diseases center – Sheba Medical Center
  • Overall Official(s)
    • Ziv Ben-Ari, MD, Principal Investigator, Sheba Medical Center
  • Overall Contact(s)
    • Avishag Hassid, MA, +972-35307176, avishag.hassid@sheba.health.gov.il

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