Hepatoscope screening and referral for people at risk of liver fibrosis
Use of Ultrasound Tools to Refer Patients at Risk of Chronic Liver Disease to the Hepatology Consultation (US-REFERRAL)
This test tries a portable Hepatoscope ultrasound in people flagged as at-risk by a FIB-4 blood score to see if it can detect liver fibrosis and prompt referral to hepatology.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Antwerp Academic / other |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06387745 on ClinicalTrials.gov |
What this trial studies
People identified in primary care as at risk for liver fibrosis by a positive FIB-4 will be offered a non-invasive Hepatoscope ultrasound exam to measure liver stiffness and ultrasound signs of fatty liver. Any patient with a liver stiffness of at least 6.5 kPa on the Hepatoscope will be referred to the tertiary hepatology clinic for further assessment. Hepatoscope measurements will be compared with the tertiary center's standard of care (hepatology-dedicated devices and clinical assessment) to determine concordance and referral accuracy. The trial enrolls consenting adults with elevated liver enzymes, type 2 diabetes, or components of metabolic syndrome and excludes those with implanted electronic devices, relevant skin wounds, pregnancy or breastfeeding, and people deprived of liberty.
Who should consider this trial
Good fit: Adults in primary care who have a positive FIB-4 or risk factors such as elevated liver enzymes, type 2 diabetes, or metabolic syndrome and who can provide written consent are ideal candidates.
Not a fit: People with active implanted electronic devices, wounds at the probe site, pregnant or breastfeeding women, and those deprived of liberty are excluded and would not participate or benefit from this procedure.
Why it matters
Potential benefit: If successful, Hepatoscope could enable earlier detection of liver fibrosis in primary care and faster referral to specialist hepatology care.
How similar studies have performed: Transient elastography devices like FibroScan have shown good accuracy for liver stiffness measurement, but portable Hepatoscope devices are newer and require validation against established hepatology measurements.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Edegem, Antwerp
- Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.