The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
Completed · Not applicable
Conditions studied: Liver Fibrosis, Liver Steatosis
In brief
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.
Key facts
- Study ID
- NCT03957070
- Run by
- Sonic Incytes
- People needed
- 140
- Starts
- 2019-02-01
- Expected to finish
- 2021-04-01
- Last updated by the study team
- 2021-11-08
Who can join
Age: 19 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- LAIR — Vancouver, British Columbia, Canada
Full record on ClinicalTrials.gov
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