Chronic Liver DiseaseOGIG-01-22-LFNCT05224037
Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch
A study testing iLivTouch in people with Chronic Liver Disease and Liver Fibrosis, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Liver Disease, Liver Fibrosis, Liver Steatoses
- What is being tested?
- iLivTouch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRussia
- Study dates
- 21 Jan 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- willingness to participate on the basis of the signed informed consent form;
- availability of the medical records
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal State Budgetary Scientific Institution "Federal Research Centre of Nutrition, Biotechnology
Moscow, 115446
About this study
Official 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.
Read the 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 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
- Chronic Liver Disease, Liver Fibrosis, Liver Steatoses
- Being tested
- iLivTouch
- Keywords
- ilivtouch, fibroscan, liver stiffness measurement, controlled attenuation parameter, non-alcoholic fatty liver disease, liver steatosis
- Medical subject headings
- Liver Cirrhosis, Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLivTouchDiagnostic test
Also called FibroScan
Eligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | This is a single-arm study. All the participants will undergo examinations with 2 devices Receives: Diagnostic Test: iLivTouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Study day 1
Secondary outcomes (5)
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
Measured: Study day 1
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
Measured: Study day 1
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
Measured: Study day 1
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
Measured: Study day 1
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
Measured: Study day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start21 Jan 2022
- Primary completion15 Mar 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Scientific Institution
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sergey Morozov, Federal State Budgetary Scientific Institution
- Investigators
- Vasily Isakov, Professor, Study chair, Federal State Budgetary Scientific Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224037
- Sponsor's protocol ID
- FGMF-2022-0005
- Acronym
- OGIG-01-22-LF
- Status last verified
- Apr 2023
- First submitted
- 25 Jan 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: depersonalised individual participants data may be shared upon reasonable request to the principal investigator after study completion
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Liver Fibrosis and Steatosis Assessment With Fibroscan and iLivTouch in Patients With Chronic Liver Diseases
- ClinicalTrials.gov ID
- NCT05224037
- Acronym / sponsor ID
- OGIG-01-22-LF / FGMF-2022-0005
- Conditions
- Chronic Liver Disease, Liver Fibrosis, Liver Steatoses
- Keywords
- ilivtouch, fibroscan, liver stiffness measurement, controlled attenuation parameter, non-alcoholic fatty liver disease, liver steatosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Federal State Budgetary Scientific InstitutionOther government
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Diagnostic Test: iLivTouchThis is a single-arm study. All the participants will undergo examinations with 2 devices |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- willingness to participate on the basis of the signed informed consent form;
- availability of the medical records
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iLivTouchAlso: FibroScanEligible subjects will undergo liver stiffness and controlled attenuation parameters examination with two devices on the same day | Diagnostic test | Study group |
Primary outcome
Liver stiffness
Time frame: Study day 1
Single assessment (Median by at least 10 measurements) of the liver stiffness in kilo pascals will be performed during examination of the subject
Controlled attenuation parameter
Time frame: Study day 1
Single assessment (Median by at least 10 measurements) of the controlled attenuation parameter in kilo pascals will be performed during examination of the subject
5 secondary outcomes
Interquartile range of liver stiffness
Time frame: Study day 1
Interquartile range of the controlled attenuation parameter
Time frame: Study day 1
Success rate
Time frame: Study day 1
Stage of liver fibrosis
Time frame: Study day 1
Stage of steatosis of the liver
Time frame: Study day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Individual participant dataSharing planned: Yes. depersonalised individual participants data may be shared upon reasonable request to the principal investigator after study completion
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasily Isakov, Professor study chair
Federal State Budgetary Scientific Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLivTouch in people with Chronic Liver Disease and Liver Fibrosis, run by Federal State Budgetary Scientific Institution at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver stiffness (time frame: Study day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.