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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EIT Technology
Sponsored by
Prof. Ziv Ben-Ari MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with chronic liver diseases

Exclusion Criteria:

  • Patients who don't have chronic liver diseases

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Biopsy: Routine tests & EIT Technology

    Routine tests & EIT Technology

    NASH : Routine tests & EIT Technology

    Arm Description

    The patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).

    The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).

    The patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT).

    Outcomes

    Primary Outcome Measures

    Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
    Comparing EIT fibrosis stage result to fibrosis stage result of validated thechnologies

    Secondary Outcome Measures

    Full Information

    First Posted
    April 3, 2018
    Last Updated
    April 3, 2018
    Sponsor
    Prof. Ziv Ben-Ari MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03492879
    Brief Title
    Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
    Official Title
    Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2018 (Anticipated)
    Primary Completion Date
    May 15, 2019 (Anticipated)
    Study Completion Date
    May 30, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Prof. Ziv Ben-Ari MD

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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: 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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Liver Disease, Fibrosis, Liver, Non-Alcoholic Fatty Liver Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    210 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Biopsy: Routine tests & EIT Technology
    Arm Type
    Experimental
    Arm Description
    The patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
    Arm Title
    Routine tests & EIT Technology
    Arm Type
    Experimental
    Arm Description
    The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
    Arm Title
    NASH : Routine tests & EIT Technology
    Arm Type
    Experimental
    Arm Description
    The patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT).
    Intervention Type
    Device
    Intervention Name(s)
    EIT Technology
    Intervention Description
    Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage
    Primary Outcome Measure Information:
    Title
    Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
    Description
    Comparing EIT fibrosis stage result to fibrosis stage result of validated thechnologies
    Time Frame
    Each technology will be performed once in 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with chronic liver diseases Exclusion Criteria: Patients who don't have chronic liver diseases
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Avishag Hassid, MA
    Phone
    +972-35307176
    Email
    avishag.hassid@sheba.health.gov.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ziv Ben-Ari, MD
    Phone
    +972-35307176
    Email
    ziv.ben-ari@sheba.health.gov.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ziv Ben-Ari, MD
    Organizational Affiliation
    Sheba Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

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

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