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Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI

NCT07305324 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

  • MASLD
  • Fibrosis of Liver

Interventions

DEVICE

FibroX

FibroX is an explainable artificial intelligence (AI) tool designed to assist primary care providers in diagnosing significant liver fibrosis (≥F2) and clinically significant portal hypertension in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). It uses routinely available clinical data (e.g., age, AST, ALT, platelets, BMI, HbA1c, creatinine) to generate a risk probability score, a triage band (rule-out, indeterminate, rule-in), and a one-line explainability panel using Shapley Additive Explanations (SHAP). Providers use FibroX during simulated patient encounters to guide diagnostic and referral decisions (e.g., order VCTE, refer to hepatology, initiate guideline-based therapy). The tool aims to improve diagnostic accuracy, increase provider trust, reduce missed diagnoses, and support guideline-concordant triage in primary care.

OTHER

Usual Care

In the usual care condition, primary care providers assess simulated patient cases using standard clinical tools available in routine practice. These include laboratory results, vital signs, problem lists, medications, and prior imaging. Providers may optionally use the FIB-4 calculator to estimate liver fibrosis risk. No AI decision support is provided. This intervention serves as the comparator to evaluate whether FibroX improves diagnostic accuracy for significant liver fibrosis (≥F2) and clinically significant portal hypertension, as well as provider trust, decision-making quality, and workflow efficiency compared to usual care.

Sponsors & Collaborators

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-15
Primary Completion
2027-05-15
Completion
2027-06-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07305324 on ClinicalTrials.gov