Clinical Trial

Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI

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Summary
The goal of this clinical trial is to learn whether an artificial intelligence (AI) tool called FibroX can help primary care providers better diagnose significant liver fibrosis (≥F2) and clinically significant portal hypertension in adults with metabolic dysfunction-associated steatotic liver disease (MASLD). The main questions it aims to answer are: * Can FibroX improve the accuracy of diagnosing significant liver fibrosis (≥F2) and clinically significant portal hypertension compared to usual care? * Is FibroX easy to use and acceptable to primary care providers in simulated clinical settings? * Do providers trust FibroX as a decision-support tool? Researchers will compare FibroX-assisted care to usual care to see if FibroX improves diagnostic accuracy, provider trust, and supports better decision-making. Participants will: * Be primary care providers (MDs, DOs, NPs, PAs) from diverse clinics * Review simulated patient cases with MASLD risk factors * Use either usual care tools (standard labs and optional FIB-4 calculator) or FibroX (AI-generated risk score, triage band, and explainability panel) * Make diagnostic and referral decisions for each case * Complete surveys on usability, trust in AI, confidence, and cognitive workload This study will help determine whether FibroX can be integrated into real-world primary care workflows to support earlier and more accurate detection of liver fibrosis and portal hypertension, potentially reducing missed diagnoses, unnecessary referrals, and improving patient outcomes.
Trial Details
NCT Number NCT07305324
Lead Sponsor Yale University
Conditions MASLD, Fibrosis of Liver
Enrollment 40 participants
Start Date 2026-06-15
Primary Completion 2027-05-15 (estimated)
Study Completion 2027-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-12-26