Status:

COMPLETED

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

Lead Sponsor:

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

Conditions:

Chronic Liver Disease

Liver Fibrosis

Eligibility:

All Genders

18-80 years

Phase:

NA

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.,...

Detailed Description

This is prospective comparative trial to assess diagnostic characteristics of non-invasive methods of liver fibrosis and steatosis assessment based on the measurement of liver stiffness. The null hypo...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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

Key Trial Info

Start Date :

January 21 2022

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2022

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05224037

Start Date

January 21 2022

End Date

December 31 2022

Last Update

April 11 2023

Active Locations (1)

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

Moscow, Russia, 115446