NCT03492879

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

May 15, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
Last Updated

April 10, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

April 3, 2018

Last Update Submit

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

EXPERIMENTAL

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

Device: EIT Technology

Routine tests & EIT Technology

EXPERIMENTAL

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

Device: EIT Technology

NASH : Routine tests & EIT Technology

EXPERIMENTAL

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

Device: EIT Technology

Interventions

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

Biopsy: Routine tests & EIT TechnologyNASH : Routine tests & EIT TechnologyRoutine tests & EIT Technology

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Liver CirrhosisNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsFatty Liver

Study Officials

  • Ziv Ben-Ari, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

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