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

Prof. Ziv Ben-Ari MD

Status: Unknown

Conditions: Fibrosis, Liver; Chronic Liver Disease; Non-Alcoholic Fatty Liver Disease

Treatments: Device: EIT Technology

Study type: Interventional

Funder types: Other

Identifiers

NCT03492879

SHEBA-17-4351-CTIL

Details and patient eligibility

About

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) .

Full 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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic liver diseases

Exclusion criteria

• Patients who don't have chronic liver diseases

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Biopsy: Routine tests & EIT Technology

Experimental group

Description:

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

Treatment:

Device: EIT Technology

Routine tests & EIT Technology

Experimental group

Description:

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

Treatment:

Device: EIT Technology

NASH : Routine tests & EIT Technology

Experimental group

Description:

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

Treatment:

Device: EIT Technology