Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
1 other identifier
interventional
210
0 countries
N/A
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) .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2018
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedStudy Start
First participant enrolled
May 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2019
CompletedApril 10, 2018
April 1, 2018
1 year
April 3, 2018
April 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Biopsy: Routine tests & EIT Technology
EXPERIMENTALThe patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
Routine tests & EIT Technology
EXPERIMENTALThe patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
NASH : Routine tests & EIT Technology
EXPERIMENTALThe patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT).
Interventions
Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage
Eligibility Criteria
You may qualify if:
- Patients with chronic liver diseases
You may not qualify if:
- Patients who don't have chronic liver diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ziv Ben-Ari, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of liver diseases center
Study Record Dates
First Submitted
April 3, 2018
First Posted
April 10, 2018
Study Start
May 15, 2018
Primary Completion
May 15, 2019
Study Completion
May 30, 2019
Last Updated
April 10, 2018
Record last verified: 2018-04