NCT06387745 Referral of Patients to Hepatology With Hepatoscope
| NCT ID | NCT06387745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Chronic Liver Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-08-22 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-08-22 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Frequently Asked Questions
Who can join the NCT06387745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Chronic Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387745 currently recruiting?
Yes, NCT06387745 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Antwerp to inquire about joining.
Where is the NCT06387745 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06387745 clinical trial?
NCT06387745 is sponsored by University Hospital, Antwerp. The trial plans to enroll 200 participants.