NCT07305324Not yet recruiting
Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI
Validation of an AI Tool for Improving MASLD Advanced Liver Fibrosis Diagnosis in Primary Care: A Provider-Level Crossover Randomized Controlled Trial Pilot
Source: ClinicalTrials.gov · Last updated 26 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 15 Jun 2026
- Primary completion date
- 15 May 2027
- Lead sponsor
- Yale University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07305324
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 15 Jun 2026 to the primary completion date, 15 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior involvement in the development or validation of the FibroX tool
Other
- Providers not actively practicing in adult primary care
- Providers with less than 0.5 FTE in clinical practice
- Inability to complete both simulation periods due to scheduling or other constraints
Who the study is looking for
- Licensed primary care providers (MD, DO, NP, or PA)
- Currently practicing in adult primary care (≥0.5 Full-Time Equivalent)
- Affiliated with one of the participating clinics (academic, community, or Federally Qualified Health Center)
- Willing and able to participate in simulated electronic health record (EHR)-based case reviews
- Able to provide informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Related publications
- An Explainable AI Tool (FibroX) for Detecting Advanced Liver Fibrosis in Adults With Type 2 Diabetes: Protocol for a Pilot Crossover Trial.JMIR Res Protoc · 2026 · PMID 41974444
This page is information, not medical advice. Discuss any trial with your doctor.