The Sonic Incytes Liver Incyte System, Assessment of Liver Fibrosis and Steatosis
NCT ID: NCT03957070
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
140 participants
INTERVENTIONAL
2019-02-01
2021-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Liver Incyte
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.
Liver Incyte
Ultrasound elasticity imaging
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Liver Incyte
Ultrasound elasticity imaging
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
19 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sonic Incytes
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
LAIR
Vancouver, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SI-CLIN-01
Identifier Type: -
Identifier Source: org_study_id