Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 210
- Primary Endpoint
- Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with chronic liver diseases
Exclusion Criteria
- •Patients who don't have chronic liver diseases
Arms & Interventions
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).
Intervention: EIT Technology (Device)
Routine tests & EIT Technology
The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT).
Intervention: EIT Technology (Device)
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).
Intervention: EIT Technology (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Prof. Ziv Ben-Ari MD
Head of liver diseases center
Sheba Medical Center