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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03492879
Other study ID # SHEBA-17-4351-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 3, 2018
Last updated April 3, 2018
Start date May 15, 2018
Est. completion date May 30, 2019

Study information

Verified date April 2018
Source Sheba Medical Center
Contact Avishag Hassid, MA
Phone +972-35307176
Email avishag.hassid@sheba.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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) .


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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 210
Est. completion date May 30, 2019
Est. primary completion date May 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with chronic liver diseases

Exclusion Criteria:

- Patients who don't have chronic liver diseases

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Prof. Ziv Ben-Ari MD

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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