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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05224037
Other study ID # FGMF-2022-0005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2022
Est. completion date December 31, 2022

Study information

Verified date April 2023
Source Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 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.


Recruitment information / eligibility

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

Study Design


Intervention

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

Locations

Country Name City State
Russian Federation Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

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
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