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

NCT ID: NCT03492879

Last Updated: 2018-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2019-05-30

Brief Summary

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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

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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).

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

EIT Technology

Intervention Type DEVICE

Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage

Routine tests & EIT Technology

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

Group Type EXPERIMENTAL

EIT Technology

Intervention Type DEVICE

Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage

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).

Group Type EXPERIMENTAL

EIT Technology

Intervention Type DEVICE

Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage

Interventions

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EIT Technology

Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with chronic liver diseases

Exclusion Criteria

* Patients who don't have chronic liver diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Ziv Ben-Ari MD

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Ziv Ben-Ari MD

Head of liver diseases center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ziv Ben-Ari, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Central Contacts

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Avishag Hassid, MA

Role: CONTACT

+972-35307176

Ziv Ben-Ari, MD

Role: CONTACT

+972-35307176

Other Identifiers

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SHEBA-17-4351-CTIL

Identifier Type: -

Identifier Source: org_study_id

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