Chronic Liver DiseaseNCT03492879
Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
A study testing EIT Technology in people with Chronic Liver Disease and Fibrosis, Liver, run by Prof. Ziv Ben-Ari MD.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease, Fibrosis, Liver, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- EIT Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic liver diseases
Who cannot join
- Patients who don't have chronic liver diseases
Trial locations and contacts
No sites are listed yet.
About this study
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) .
Read the 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).
- Being tested
- EIT Technology
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EIT TechnologyDevice
Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: EIT Technology |
| Routine tests & EIT Technology | Experimental | The patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT). Receives: 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). Receives: Device: EIT Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT)
Comparing EIT fibrosis stage result to fibrosis stage result of validated thechnologies
Measured: Each technology will be performed once in 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start15 May 2018 (estimated)
- Primary completion15 May 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof. Ziv Ben-Ari MD
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Prof. Ziv Ben-Ari MD, Sheba Medical Center
- Investigators
- Ziv Ben-Ari, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492879
- Sponsor's protocol ID
- SHEBA-17-4351-CTIL
- Status last verified
- Apr 2018
- First submitted
- 3 Apr 2018
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Invasive Electrical Impedance Technology (EIT) for Diagnosing Liver Diseases Severity
- ClinicalTrials.gov ID
- NCT03492879
- Acronym / sponsor ID
- SHEBA-17-4351-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Prof. Ziv Ben-Ari MDOther government
- Study start
- 15 May 2018 (estimated)
- Primary completion
- 15 May 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biopsy: Routine tests & EIT Technology | Experimental | Device: EIT TechnologyThe patients will undergo a routine liver biopsy and also routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT). |
| Routine tests & EIT Technology | Experimental | Device: EIT TechnologyThe patients will undergo a routine liver Ultrasonography, Shear wave elastography and Electrical Impedance Technology (EIT). |
| NASH : Routine tests & EIT Technology | Experimental | Device: EIT TechnologyThe patients will undergo a routine liver Ultrasonography, Shear wave elastography and quantification of liver steatosis using the Electrical Impedance Technology (EIT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic liver diseases
Key exclusion criteria (1 listed)
- Patients who don't have chronic liver diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EIT TechnologyElectrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage | Device | Biopsy: Routine tests & EIT Technology, NASH : Routine tests & EIT Technology, Routine tests & EIT Technology |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ziv Ben-Ari, MD principal investigator
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing EIT Technology in people with Chronic Liver Disease and Fibrosis, Liver, run by Prof. Ziv Ben-Ari MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Avishag Hassid, MA (+972-35307176, avishag.hassid@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the liver fibrosis stage using Electrical Impedance Technology (EIT) (time frame: Each technology will be performed once in 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2018.