Clinical Trials Logo
  1. Home
  2. Other
  3. NCT03492879
  4. Details
NCT03492879 Clinical Trial

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

Non-Alcoholic Fatty Liver Disease Clinical Trial

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

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
See also
  Status Clinical Trial Phase
Recruiting NCT05480696 - Soluble Fibre Supplementation in NAFLD Phase 1
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Completed NCT04671186 - Role of Probiotics in Treatment of Pediatric NAFLD Patients by Assessing With Fibroscan N/A
Recruiting NCT05979779 - Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis Phase 2
Recruiting NCT05462353 - Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH Phase 2
Completed NCT05006885 - ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD) Phase 1
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT04365855 - The Olmsted NAFLD Epidemiology Study (TONES) N/A
Recruiting NCT05618626 - Prevention of NAFLD and CVD Through Lifestyle Intervention N/A
Completed NCT03256526 - 6-week Safety and PD Study in Adults With NAFLD Phase 2
Enrolling by invitation NCT06152991 - Clinical Trial Assessing Godex Carnitine Orotate Complex in Nonalcoholic Fatty Liver Disease Patients for Efficacy Phase 3
Completed NCT03681457 - Evaluation of the Pharmacokinetics of Tropifexor in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Healthy Control Subjects Phase 1
Completed NCT06244550 - Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors N/A
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Completed NCT03060694 - Screening Diabetes Patients for NAFLD With Controlled Attenuation Parameter and Liver Stiffness Measurements
Completed NCT02526732 - Hepatic Inflammation and Physical Performance in Patients With NASH N/A
Recruiting NCT01988441 - The Influence of Autophagy on Fatty Liver
Recruiting NCT01680003 - Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease Phase 2
Completed NCT01712711 - Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease Phase 2
Recruiting NCT00941642 - Placebo Controlled Study Using Lovaza as Treatment for Non-Alcoholic Fatty Liver Disease Phase 4