Non-Alcoholic Fatty Liver Disease Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Universitair Ziekenhuis Antwerpen
RECRUITING
Edegem
Time Frame
Start Date: 2025-08-22
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
Experimental: Investigational Arm
Single arm study protocol
Sponsors
Collaborators: E-Scopics
Leads: University Hospital, Antwerp

This content was sourced from clinicaltrials.gov