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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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 hypothesis is that novel device, iLivTouch FT100/FT200 and standard probe allows to obtain similar results of liver stiffness and controlled attenuation parameter compared to FibroScan 530 and probes M+ and XL+ in patients with chronic liver diseases. According to the study protocol, standard examination will be performed to eligible subjects on the same day with the use of both devices. At least 10 measurements will be performed with the use of each device to each subject after overnight fasting. The medians of liver stiffness and controlled attenuation parameter measurements, their interquartile range, success rate of measurements and related interpretations of the results (grades of liver fibrosis and steatosis) will be compared. To assess the variability of the results, demographic data (age, biological sex, ethnicity) will be collected; weight and height of the subjects will be measured on the day of examination. Medical history of the subjects will be examined to extract data, confirming the presence of chronic liver diseases and ensure eligibility.

Conditions

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Chronic Liver Disease Liver Fibrosis Liver Steatoses

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Study group

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

Group Type EXPERIMENTAL

iLivTouch

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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iLivTouch

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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FibroScan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes