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
About this trial
This is an interventional diagnostic trial for Chronic Liver Disease
Eligibility Criteria
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
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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