RecruitingNot ApplicableNCT06387745

Referral of Patients to Hepatology With Hepatoscope

Use of Ultrasound Tools to Refer Patients at Risk of Chronic Liver Disease to the Hepatology Consultation (US-REFERRAL)

Sponsor

University Hospital, Antwerp

Enrollment

200 participants

Start Date

Aug 22, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Liver Disease

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria4

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.

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Interventions

DEVICEHepatoscope

The Hepatoscope is a non-invasive external ultrasound imaging device, intended for general purpose pulse echo ultrasound imaging, and soft tissue elasticity imaging of the human body. In addition, the Hepatoscope provides measurements of shear wave speed and tissue stiffness, ultrasound beam attenuation and estimates of speed of sound, in internal structures of the body.