OnX Liver Assessment Solution Clinical Study

R
Raj Vuppalanchi, MD

Primary Investigator

Enrolling By Invitation
22 years - 80 years
All
Phase N/A
1 participants needed
1 Location

Brief description of study

What is the purpose of this study?
This protocol’s primary aim is to assess the performance of the OnX exam on patients with suspected or confirmed liver disease with the goal of comparing the OnX output stiffness estimates to FibroScan® liver stiffness measurements. Our primary objectives are to assess whether the OnX stiffness estimates are non-inferior to FibroScan® liver stiffness measurements in kPa. Our secondary objectives are to compare OnX liver stiffness estimate boundaries to FibroScan® liver stiffness measure in kPa in healthy patients vs. patients with stiffness estimates indicative of varying degrees of fibrosis and to assess safety of OnX in terms of feasibility and tolerability of results.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Prospective participants will be recruited from among those seen in clinic by a Hepatology care provider and will be contacted in person during their clinic appointment about study participation.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Hepatocellular chronic liver disease, CLD, NAFLD, NAFL, NASH, Chronic HBV, HCV
  • Age: 22 years - 80 years
  • Gender: All

Inclusion Criteria

●    Patients (any sex, age 22-80) with confirmed diagnosis of hepatocellular chronic liver disease (CLD) including NAFLD (NAFL/NASH), Chronic HBV (presence of detectable HbsAg for more than 6 months) and/or HCV and have previously undergone fibrosis staging either by liver biopsy (within 2-8 weeks prior to OnX scan) or elastography (transient elastography, shear wave elastography, MRE). 
●    Patients (any sex, age 22-80) with suspected hepatocellular chronic liver disease (CLD) including NAFLD (NAFL/NASH), Chronic HBV (presence of detectable HbsAg for more than 6 months) and/or HCV.
●    Ability to understand and willingness to sign a written informed consent document.
●    Patients must be fasting for 3 hours, prior to both the OnX scan and FibroScan® exam.

Exclusion Criteria

●    Age <22 or >80
●    Inability to consent
●    Active, documented jaundice, cholestasis or elevated total bilirubin levels 1.5 -2 x ULN (> 1.2 mg/dL or 20.5 µmol/L)
●    Documented or known ascites
●    Documented or known portal hypertension secondary to non-cirrhotic etiologies (Budd-Chiari syndrome, congestive heart failure, extrahepatic portal vein thrombosis)
●    History of solid organ transplant
●    Prior diagnosis of hepatocellular carcinoma, cholangiocarcinoma or metastatic carcinoma
●    BMI greater than 32 kg/m2Berger et al. (2019)* 
●    Individuals with acute abdominal conditions, ascites, local skin diseases and severe musculoskeletal disorders that would not allow comfortable ultrasound assessment of the liver
●    Pregnant or suspicion of pregnancy
●    Individuals with current ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average [1 standard drink = 12 grams of alcohol])
●    Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators
●    History of Primary Biliary Cholangitis / Primary Sclerosing Cholangitis
●    History of autoimmune hepatitis 
●    History of congestive heart failure
●    Acute viral hepatitis A infection 
●    Acute or Chronic Hepatitis B with ALT levels ≥2 X ULN (or >35 U/L for men or >25 U/L for women)1  
●    Previous HCV infection and unable to achieve SVR12 with previous antiviral treatment for HCV
●    Drug Induced Liver Injury
●    Liver disease related to other systemic etiologies, including human immunodeficiency virus (HIV) infection, Wilson’s disease, hemochromatosis, alpha-1 antitrypsin deficiency, amyloidosis.

Updated on 26 Nov 2024. Study ID: GI-ONCOUSTICS-ONX510K, 24720
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