Liver Fibrosis Clinical Trial
Official title:
The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Verified date | November 2021 |
Source | Sonic Incytes |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | April 1, 2021 |
Est. primary completion date | April 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 19 Years to 75 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | LAIR | Vancouver | British Columbia |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Sonic Incytes |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Agreement between Liver Incytes and MRI elastography measurements | Elasticity measurements from Liver Incyte and MRE will be compared using a concordance correlation coefficient and associated 95% confidence intervals. A Spearman correlation coefficient and 95% confidence intervals will also be calculated. As in the analysis for the Primary Objective, an ROC curve will be constructed and AUCs for differentiating healthy versus fibrotic (HVC/NASH) will be calculated. | 6 months | |
Other | Correlation between Liver Incytes and MRI elastography measurements | Steatosis measurements from Liver Incyte, Fibroscan (CAP), and MRI (PDFF) will be compared using a concordance correlation coefficient and associated 95% confidence intervals. A Spearman correlation coefficient and 95% confidence intervals will also be calculated. An ROC curve will be constructed and AUCs for differentiating healthy versus fibrotic (HCV/NASH) will be calculated. | 6 months | |
Primary | 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 | 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 |
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