Liver FibrosisNCT03957070
The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
A study testing Liver Incyte in people with Liver Fibrosis and Liver Steatosis, run by Sonic Incytes at 2 sites in 2 countries.
Trial summary
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan… Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Liver Fibrosis, Liver Steatosis
- What is being tested?
- Liver Incyte
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2019to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any sex, ages 19-75 years inclusively
- Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12).
- Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals.
- Able to understand the informed consent form, study procedures and willing to participate in study
Who cannot join
- Unable to achieve SVR12 with previous antiviral treatment for HCV
- Multiple (>1) liver disease diagnoses within the past 12 months
- Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years
- Documented or known ascites
- Documented or known portal hypertension
- BMI greater than 35 kg/m2 (30 kg/m2 for optional MRE participants)
Show all 10Show fewer
- If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
- Individuals with history of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average [1 standard drink = 10 grams of alcohol])
- Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators.
- Individuals with surgically removed gallbladder (for optional MRE procedure only)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.
Read the detailed description
This will be a prospective, open label, feasibility and validation study of the Liver Incyte system in patients with liver fibrosis (Cohort 1, n = 150) and healthy volunteers (Cohort 2, n = 50), for a total of 200 participants. The physician operator of the FibroScan, and the operator of the Shear wave vibro-elastography (S-WAVE) system, will not be blinded to the clinical diagnoses of the patients. All patients will undergo the testing with both FibroScan and Liver Incyte system at a single in-clinic visit.
The liver stiffness of each participant will be assessed with the Liver Incyte Model B device and with FibroScan. The elasticity measurements from these two devices will be the primary outcome measure.
The Liver Incyte system is designed as two models with differences in the ultrasound components only, description of the two models is below. Two sub-studies are included in this design as exploratory objectives. Model B will be utilized at all study sites and all study participants. Participants at the LAIR study site will also be evaluated using Model A, as well as Model B, for verification and to confirm consistency between designs. Participants will have the option to participate in the Magnetic Resonance Elastography (MRE) and Proton Density Fat Fraction (PDFF) portion of the study. MRE/PDFF is an optional procedure, which makes up a sub-study for this trial, this would require approximately 1 hour, and is open to any participant who is willing and has time for the extra study visit. The results of the MRE/PDFF sub-study will be included as an exploratory objective.
- Conditions
- Liver Fibrosis, Liver Steatosis
- Being tested
- Liver Incyte
- Keywords
- liver, ultrasound elastography
- 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.
Liver IncyteDevice
Ultrasound elasticity imaging
| Study group | Role | What they receive |
|---|---|---|
| Liver Incyte with patients with successfully treated HCV, or NAFLD/NASH | Active comparator | Patients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte. Receives: Device: Liver Incyte |
| Liver Incyte with healthy volunteers with no history of liver disease. | Active comparator | Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte. Receives: Device: Liver Incyte |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination of Healthy Volunteers From Patients With Liver Fibrosis
The discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements. All measurements were collected at a single timepoint for each patient. Both measurements were collected on the same day. No longitudinal data was collected.
An receiver operating characteristic (ROC) curve using final Liver Incyte elasticity measurement as a predictor of healthy versus fibrotic (HCV/NASH) will be constructed with accompanying 95% confidence interval for the area under the curve (AUC). The AUC and 95% confidence intervals for the FibroScan device will be calculated.
Measured: Baseline
Secondary outcomes (1)
Safety of the Device as Measured by Rate of Adverse Events
The safety and tolerability of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis
Total number of adverse events when using the investigational device will be reported.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Feb 2019
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sonic Incytes
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957070
- Sponsor's protocol ID
- SI-CLIN-01
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2019
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Curry MP, Tam E, Schneider C, Abdelgelil N, Hassanien T, Afdhal NH. The Use of Noninvasive Velacur(R) for Discriminating between Volunteers and Patients with Chronic Liver Disease: A Feasibility Study. Int J Hepatol. 2024 Jan 17;2024:8877130. doi: 10.1155/2024/8877130. eCollection 2024.
PubMed 38274398
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
- ClinicalTrials.gov ID
- NCT03957070
- Acronym / sponsor ID
- SI-CLIN-01
- Conditions
- Liver Fibrosis, Liver Steatosis
- Keywords
- liver, ultrasound elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Sonic IncytesIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 21 May 2019 (actual)
- Results
- Posted 15 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.
Detailed description
This will be a prospective, open label, feasibility and validation study of the Liver Incyte system in patients with liver fibrosis (Cohort 1, n = 150) and healthy volunteers (Cohort 2, n = 50), for a total of 200 participants. The physician operator of the FibroScan, and the operator of the Shear wave vibro-elastography (S-WAVE) system, will not be blinded to the clinical diagnoses of the patients. All patients will undergo the testing with both FibroScan and Liver Incyte system at a single in-clinic visit.
The liver stiffness of each participant will be assessed with the Liver Incyte Model B device and with FibroScan. The elasticity measurements from these two devices will be the primary outcome measure.
The Liver Incyte system is designed as two models with differences in the ultrasound components only, description of the two models is below. Two sub-studies are included in this design as exploratory objectives. Model B will be utilized at all study sites and all study participants. Participants at the LAIR study site will also be evaluated using Model A, as well as Model B, for verification and to confirm consistency between designs. Participants will have the option to participate in the Magnetic Resonance Elastography (MRE) and Proton Density Fat Fraction (PDFF) portion of the study. MRE/PDFF is an optional procedure, which makes up a sub-study for this trial, this would require approximately 1 hour, and is open to any participant who is willing and has time for the extra study visit. The results of the MRE/PDFF sub-study will be included as an exploratory objective.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liver Incyte with patients with successfully treated HCV, or NAFLD/NASH | Active comparator | Device: Liver IncytePatients with successfully treated HCV, or NASH Patients and Volunteers will be scanned with FibroScan and Liver Incyte. |
| Liver Incyte with healthy volunteers with no history of liver disease. | Active comparator | Device: Liver IncyteHealthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any sex, ages 19-75 years inclusively
- Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12).
- Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals.
- Able to understand the informed consent form, study procedures and willing to participate in study
Key exclusion criteria (10 listed)
- Unable to achieve SVR12 with previous antiviral treatment for HCV
- Multiple (>1) liver disease diagnoses within the past 12 months
- Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years
- Documented or known ascites
- Documented or known portal hypertension
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 |
|---|---|---|
| Liver IncyteUltrasound elasticity imaging | Device | Liver Incyte with healthy volunteers with no history of liver disease., Liver Incyte with patients with successfully treated HCV, or NAFLD/NASH |
Primary outcome
Discrimination of Healthy Volunteers From Patients With Liver Fibrosis
Time frame: Baseline
The discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements. All measurements were collected at a single timepoint for each patient. Both measurements were collected on the same day. No longitudinal data was collected. An receiver operating characteristic (ROC) curve using final Liver Incyte elasticity measurement as a predictor of healthy versus fibrotic (HCV/NASH) will be constructed with accompanying 95% confidence interval for the area under the curve (AUC). The AUC and 95% confidence intervals for the FibroScan device will be calculated.
1 secondary outcome
Safety of the Device as Measured by Rate of Adverse Events
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38274398Curry MP, Tam E, Schneider C, Abdelgelil N, Hassanien T, Afdhal NH. The Use of Noninvasive Velacur(R) for Discriminating between Volunteers and Patients with Chronic Liver Disease: A Feasibility Study. Int J Hepatol. 2024 Jan 17;2024:8877130. doi: 10.1155/2024/8877130. eCollection 2024.
- Individual participant dataSharing planned: No
Related trials for Liver Fibrosis
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Incyte in people with Liver Fibrosis and Liver Steatosis, run by Sonic Incytes at 2 sites in 2 countries.
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 4 inclusion and 10 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Discrimination of Healthy Volunteers From Patients With Liver Fibrosis (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03957070, which also lists 1 linked publication.
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 15 Sep 2026.