Liver Fibrosis Clinical Trial
— OGIG-01-22-LFOfficial title:
Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch in Patients With Chronic Liver Diseases
This study is aimed to compare the results and operating characteristics of liver stiffness measurement with the use of Fibroscan (EchoSens, France) and iLivTouch (Wuxi Hisky Medical Technologies Co., China) in patients with chronic liver diseases.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | March 15, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - willingness to participate on the basis of the signed informed consent form; - availability of the medical records Exclusion Criteria: - pregnancy and breastfeeding; - narrow intercostal spaces making standard examination of the liver stiffness possible; - extreme obesity, in cases when amount of the fat tissue in right lower part of chest makes impossible to perform measurements; - ascites; - focal lesions of the liver (including, but not limited to liver cancer or metastases of cancer regardless of their origin, parasitic invasions, cysts) in projection of the measurements; - impossibility to perform evaluation with both devices due to any reasons; - any health-related conditions of a subject that put him/her at risk in case the procedures required per study protocol are performed or making him/her ineligible on the discretion of the investigator |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology | Moscow |
Lead Sponsor | Collaborator |
---|---|
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Liver stiffness | Single assessment (Median by at least 10 measurements) of the liver stiffness in kilo pascals will be performed during examination of the subject | Study day 1 | |
Primary | Controlled attenuation parameter | Single assessment (Median by at least 10 measurements) of the controlled attenuation parameter in kilo pascals will be performed during examination of the subject | Study day 1 | |
Secondary | Interquartile range of liver stiffness | Single assessment (interquartile range by at least 10 measurements) of the liver stiffness in kilo pascals will be performed during examination of the subject | Study day 1 | |
Secondary | Interquartile range of the controlled attenuation parameter | Single assessment of interquartile range of the controlled attenuation parameter (by at least 10 measurements) in kilo pascals will be performed during examination of the subject | Study day 1 | |
Secondary | Success rate | Success rate (a quotient of division of number of successful measurement on the total of number of measurements performed during examination of a subject) with iLivTouch and Fibroscan | Study day 1 | |
Secondary | Stage of liver fibrosis | stage of liver fibrosis according to the liver stiffness and manufacturers instruction on the interpretation of the results of iLivTouch and FibroScan | Study day 1 | |
Secondary | Stage of steatosis of the liver | stage of liver fibrosis according to the measurement of the controlled attenuation parameter obtained during examination of a subject and manufacturers instruction on the interpretation of the results of iLivTouch and FibroScan | Study day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06308757 -
Role of the Very Low Calorie Ketogenic Diet (VLCKD) in Patients With Non-Alcoholic Steatohepatitis (NASH) With Fibrosis
|
N/A | |
Recruiting |
NCT06051669 -
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
|
||
Completed |
NCT06244550 -
Clinical Trials Using HepatoKeeper Herbal Essentials to Treat Non-alcoholic Fatty Liver Disease and Metabolic Factors
|
N/A | |
Recruiting |
NCT06098417 -
Biomarkers in the Diagnosis and Prognosis of NAFLD
|
||
Not yet recruiting |
NCT03623360 -
Functional MRI to Determine Severity of Cirrhosis
|
||
Recruiting |
NCT01965418 -
A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
|
Phase 4 | |
Not yet recruiting |
NCT01133184 -
Improved Prevention of Perinatal Hepatitis B Transmission
|
Phase 4 | |
Completed |
NCT00043303 -
Safety and Efficacy Study of Interferon Gamma-1b in Hepatitis C Patients With Liver Fibrosis or Cirrhosis
|
Phase 2 | |
Completed |
NCT03872024 -
Performances Evaluation of New FibroScan Probes Dedicated to Morbidly Obese Patients
|
N/A | |
Recruiting |
NCT05912179 -
Prospective Single Centre Observational Study to Compare the Diagnostic Yield of Different Modalities of Liver Biopsy
|
||
Recruiting |
NCT04533828 -
68Ga-FAPI PET/CT in Liver Fibrosis Patients
|
Early Phase 1 | |
Completed |
NCT04573543 -
The Role of Immune Semaphorins in NAFLD
|
||
Recruiting |
NCT03277651 -
Noninvasive Diagnostic Platform for Liver Fibrosis and Portal Hypertension
|
N/A | |
Completed |
NCT01707472 -
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
|
Phase 2 | |
Completed |
NCT01934777 -
Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
|
Phase 3 | |
Completed |
NCT01810458 -
Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)
|
||
Completed |
NCT02060162 -
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
|
||
Completed |
NCT01988753 -
Non-invasive Biomarkers of Fibrosis in Pediatric Liver Diseases
|
||
Completed |
NCT00049842 -
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
|
Phase 3 | |
Recruiting |
NCT06063785 -
Multispectral Optoacoustic Tomography in Patients With Cystic Fibrosis
|