Liver FibrosisNCT06051669
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
An observational study of Liver Fibrosis and Fatty Liver, run by New Discovery LLC at 4 sites in United States.
Trial summary
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Fibrosis, Fatty Liver
- What is being tested?
- iLivTouch and FibroScan
- Type of treatment
- Medical device
- How many people
- 418 participants
- Where
- 4 sitesUnited States
- Study dates
- 24 Sep 2023to Mar 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The following conditions are considered as patient withdrawal from the current study: * Patient withdrawal of informed consent at any time during the study; * The lack of adherence to the protocol to complete the tests by two devices.
Who may be able to join
- a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
- b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
- c. Patients who are willing to participate in the clinical study and can sign ICF.
Who cannot join
- a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
- b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST >100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) > 1.8 mg/d (or >1.5 × ULN =1.2 mg/d);
- c. Patients with a history or current evidence of decompensated liver cirrhosis;
- d. Patients with various space-occupying tumors and cysts in the right liver;
- e. Patients with other serious systemically diseases or a history of malignant tumors;
- f. Patients with ascites;
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- g. Patients with a non-healing wound on the right upper abdomen at this moment;
- h. Patients with intracavitary implantation of instruments;
- i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening);
- j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation);
- k. Lack of or limited legal capacity.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Not yet recruiting
Rush University
Chicago, Illinois, 60612
Nancy Reau, Dr
- Not yet recruiting
Baylor University
Houston, Texas, 76798
Prasun K Jalal, Dr
- Recruiting
NYU Langone
New York, New York, 11355
Calvin Q Pan, Dr
- Not yet recruiting
Stanford University
Redwood City, California, 94305
Ray Kim, Dr
About this study
Official title: Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study
This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.
Read the detailed description
Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA
Objectives:
- Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
- Secondary Objectives
- To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
- To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
- The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.
- Conditions
- Liver Fibrosis, Fatty Liver
- Being tested
- iLivTouch, FibroScan
- Medical subject headings
- Liver Cirrhosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLivTouchDevice
The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results.
FibroScanDevice
The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results.
| Study group | Role | What they receive |
|---|---|---|
| iLivTouch then FibroScan | Subjects in the Group "iLivTouch then FibroScan" will be measured using iLivTouch first and then FibroScan based on the randomization result. Receives: Device: iLivTouch; Device: FibroScan | |
| FibroScan then iLivTouch | Subjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result. Receives: Device: iLivTouch; Device: FibroScan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (LSM) between iLivTouch-FT9000 and FibroScan 530 devices.
Measured: 6 months
Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
Measured: 6 months
Secondary outcomes (6)
To compare the success rate of the iLivTouch and FibroScan
The success rate of examination will be obtained from the percentage of patients who are successful in the test.
Measured: 6 months
To compare the number of effective examinations of iLivTouch and FibroScan
The number of effective examinations will be obtained from the number of attempts to obtain the effective results.
Measured: 6 months
Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)
To compare LSM obtained from each device with liver stiffness estimated by APRI.
Two liver fibrosis detection results based on LSM and APRI will be compared. The higher values mean more serious fibrosis.
Measured: 6 months
Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)
Two liver fibrosis detection results based on LSM and FIB-4 will be compared. FIB-4 refers to Age (years), AST Level (U/L), Platelet Count (10^9/L), ALT (U/L), with higher values mean more serious fibrosis.
Measured: 6 months
Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores
Two liver fibrosis detection results based on LSM and SAFE scores will be compared. The higher values mean more serious fibrosis.
Measured: 6 months
Adverse events, serious events
The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start24 Sep 2023
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Discovery LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health, Stanford University, Rush University, Baylor University, Wuxi Hisky Medical Technology Co Ltd
- Responsible party
- Sponsor
- Investigators
- Calvin Q. Pan, Study chair, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051669
- Sponsor's protocol ID
- ILT-US-2023-01
- Status last verified
- Oct 2023
- First submitted
- 1 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study
- ClinicalTrials.gov ID
- NCT06051669
- Acronym / sponsor ID
- ILT-US-2023-01
- Conditions
- Liver Fibrosis, Fatty Liver
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- New Discovery LLCIndustry (pharma, biotech, devices)
- Collaborators
- NYU Langone Health, Stanford University, Rush University, Baylor University, Wuxi Hisky Medical Technology Co Ltd
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 25 Sep 2023 (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 is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.
Detailed description
Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA
Objectives:
- Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
- Secondary Objectives
- To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
- To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
- The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iLivTouch then FibroScan | – | Device: iLivTouch, Device: FibroScanSubjects in the Group "iLivTouch then FibroScan" will be measured using iLivTouch first and then FibroScan based on the randomization result. |
| FibroScan then iLivTouch | – | Device: iLivTouch, Device: FibroScanSubjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The following conditions are considered as patient withdrawal from the current study: * Patient withdrawal of informed consent at any time during the study; * The lack of adherence to the protocol to complete the tests by two devices.
Key inclusion criteria (3 listed)
- a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
- b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
- c. Patients who are willing to participate in the clinical study and can sign ICF.
Key exclusion criteria (11 listed)
- a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
- b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST >100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) > 1.8 mg/d (or >1.5 × ULN =1.2 mg/d);
- c. Patients with a history or current evidence of decompensated liver cirrhosis;
- d. Patients with various space-occupying tumors and cysts in the right liver;
- e. Patients with other serious systemically diseases or a history of malignant tumors;
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 |
|---|---|---|
| iLivTouchThe examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results. | Device | FibroScan then iLivTouch, iLivTouch then FibroScan |
| FibroScanThe examination with FibroScan will be performed in each subject following the sequence determined by the randomization results. | Device | FibroScan then iLivTouch, iLivTouch then FibroScan |
Primary outcome
Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
Time frame: 6 months
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (LSM) between iLivTouch-FT9000 and FibroScan 530 devices.
Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection
Time frame: 6 months
Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
6 secondary outcomes
To compare the success rate of the iLivTouch and FibroScan
Time frame: 6 months
To compare the number of effective examinations of iLivTouch and FibroScan
Time frame: 6 months
Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)
Time frame: 6 months
Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)
Time frame: 6 months
Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores
Time frame: 6 months
Adverse events, serious events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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.
Calvin Q. Pan study chair
NYU Langone Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibrosis and Fatty Liver, run by New Discovery LLC at 4 sites in United States.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Calvin Q Pan, Dr ((718) 888-7728, Panc01@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection (time frame: 6 months). 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 13 Oct 2023.