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Referral of Patients to Hepatology With Hepatoscope

RecruitingNAAges 18 Years - 80 YearsAllUniversity Hospital, Antwerp
NCT06387745 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Hepatoscope
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Where

1 site
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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