About this trial
Patients identified as being at risk of liver fibrosis because of a positive Fibrosis-4 (FIB-4) test in the primary care setting will be offered be enrolled in the trial and to undergo an Hepatoscope exam (external non-invasive ultrasound imaging exam) to screen for liver fibrosis (with stiffness measurements) and/or steatosis (with ultrasound parameters related to fatty liver). All patients presenting with a liver stiffness value of at least 6.5 kilopascal (kPa) will be referred to the tertiary hepatology consultations for further assessment. Hepatoscope measurements will be compared to the standard of care for these patients, as defined at the tertiary hepatology center.
Eligibility criteria
Qualifiers
Patients with any of the following
Elevated liver enzymes (AST, ALT, Gamma-GT, AP)
Type 2 diabetes
Elements of metabolic syndrome
Disqualifiers
Patients with active implants such as pacemakers, defibrillators, pumps, etc.
Patients presenting wounds at the location where the Hepatoscope probe shall be placed on patients' skin,
Pregnant and breastfeeding women,
People deprived of their freedom rights.
Trial design
Treatments tested in this trial
- Hepatoscope
Treatment groups
Sponsors and collaborators
University Hospital, Antwerp
Lead sponsor
E-Scopics
Collaborator