Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch

NCT05224037 | Completed DMC

• 1 other identifier: FGMF-2022-0005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Liver Disease; Liver Fibrosis; Liver Steatoses

Keywords

ilivtouch; fibroscan; liver stiffness measurement; controlled attenuation parameter; non-alcoholic fatty liver disease; liver steatosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Interquartile range of liver stiffness

  Study day 1

• Interquartile range of the controlled attenuation parameter

  Study day 1

• Success rate

  Study day 1

• Stage of liver fibrosis

  Study day 1

• Stage of steatosis of the liver

  Study day 1

Study Arms (1)

Study group

EXPERIMENTAL

This is a single-arm study. All the participants will undergo examinations with 2 devices

Diagnostic Test: iLivTouch

Interventions

iLivTouch DIAGNOSTIC_TEST

Eligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day

Also known as: FibroScan

Study group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• willingness to participate on the basis of the signed informed consent form;
• availability of the medical records

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology: lead

Study Sites (1)

Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

Moscow, 115446, Russia

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vasily Isakov, Professor

  Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading researcher

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 4, 2022
• Study Start: January 21, 2022
• Primary Completion: March 15, 2022
• Study Completion: December 31, 2022
• Last Updated: April 11, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: after study completion
• Access Criteria: request to the investigator

Locations

RU (1)