This multi-center pilot study will evaluate the feasibility, safety, and clinical relevance of an investigational AI-assisted wide-field fluorescence endoscopy system for assessment of colonic mucosal permeability in inflammatory bowel disease (IBD). The study will enroll 70 adults across 3 Canadian academic centers, including 60 patients with ulcerative colitis or Crohn's disease involving the colon who are undergoing clinically indicated colonoscopy, and 10 non-IBD controls undergoing routine colorectal cancer screening or surveillance.
Impaired intestinal barrier function is an important feature of IBD, but current permeability tests do not provide direct, segment-specific, real-time information during colonoscopy. In this study, standard colonoscopy will be supplemented by intravenous fluorescein and fluorescence imaging during scope withdrawal, together with scope-position tracking and AI-assisted video analysis. The investigational system is designed to generate regional permeability measurements based on fluorescence leakage patterns along the colonic mucosa.
The primary objective is to determine whether this imaging approach can be safely and feasibly integrated into routine colonoscopy and produce interpretable permeability data. Secondary objectives are to evaluate whether fluorescence-derived permeability measurements correlate with regional endoscopic disease activity, matched histopathology, and ex vivo Ussing chamber permeability measurements at the McMaster site. Non-IBD controls are included to provide reference fluorescence and permeability data for non-inflamed mucosa.
This is a non-randomized, observational study in which all participants will undergo the same investigational imaging procedure in addition to standard care. The study is intended to generate preliminary data to support future trials of fluorescence-based permeability mapping as a tool for assessing mucosal barrier dysfunction in IBD.
