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Referral of Patients to Hepatology With Hepatoscope

RECRUITINGN/ASponsored by University Hospital, Antwerp
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Antwerp
Started2025-08-22
Est. completion2026-08
Eligibility
Age18 Years – 80 Years
Healthy vol.Accepted

Summary

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

Age: 18 Years – 80 YearsHealthy volunteers accepted
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.

Conditions2

Chronic Liver DiseaseLiver Disease

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