The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis

Conditions
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Liver Fibrosis, Liver Steatosis

Intervention / Treatment
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* Device: Liver Incyte


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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) 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)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver Incyte<br>Patients with successfully treated HCV, or NASH Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte. | Device: Liver Incyte<br>* Ultrasound elasticity imaging<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discrimination of healthy 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. 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Rate of adverse events when using the investigational device will be reported. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver, ultrasound elastography