Referral of Patients to Hepatology With Hepatoscope

Recruiting now · Not applicable

Conditions studied: Chronic Liver Disease

In brief

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.

Key facts

Study ID

NCT06387745

Run by

University Hospital, Antwerp

People needed

200

Starts

2025-08-22

Expected to finish

2026-12-01

Last updated by the study team

2026-05-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium (enrolling)

Full record on ClinicalTrials.gov

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