Referral of Patients to Hepatology With Hepatoscope

Launched by UNIVERSITY HOSPITAL, ANTWERP · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new way to check for liver problems in patients who may be at risk for liver damage, particularly those with chronic liver disease. If a patient's initial test, called the Fibrosis-4 (FIB-4) test, shows a risk of liver fibrosis, they will be invited to participate in the trial. Participants will undergo a non-invasive exam using a device called a Hepatoscope, which uses ultrasound to measure how stiff the liver is and to check for fatty liver. If the test shows a liver stiffness value of 6.5 kPa or higher, these patients will be referred to a specialist for further evaluation.

To be eligible for this trial, participants must be between the ages of 65 and 74 or 29 and 219 and have certain health conditions, such as elevated liver enzymes or Type 2 diabetes. They must also agree to participate in the study after being informed about its purpose. However, some people cannot join, including those with certain medical devices like pacemakers, pregnant or breastfeeding women, and individuals who have wounds where the Hepatoscope will be placed. This trial aims to improve how we identify and manage liver diseases, offering a potentially easier and safer way to monitor liver health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with any of the following
• • Elevated liver enzymes (AST, ALT, Gamma-GT, AP)
• • Type 2 diabetes
• • Elements of metabolic syndrome
• • Patients who consent in written to participate in the Clinical Investigation after being orally informed on the objectives and methods of the Clinical Investigation
• Exclusion Criteria:
• • 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 Officials