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AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls

NCT07546955 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2026-04-23

No results posted yet for this study

Summary

This pilot study will test a new imaging system that uses fluorescent dye and artificial intelligence (AI) during colonoscopy to measure how "leaky" the lining of the colon is in people with inflammatory bowel disease (IBD). The study will include 70 adults at 3 Canadian hospitals: 60 people with ulcerative colitis or Crohn's disease affecting the colon, and 10 people without IBD who are having colonoscopy for routine colorectal cancer screening or surveillance. During the colonoscopy, participants will receive intravenous fluorescein, and the imaging system will record fluorescence in the colon as the scope is withdrawn. The main goal is to find out whether this method can be used safely during routine colonoscopy and whether it can produce usable measurements of mucosal permeability. The study will also examine whether these measurements are related to standard measures of inflammation seen during endoscopy, in biopsy samples, and in ex vivo Ussing chamber testing at the McMaster site. The control group will help define what normal fluorescence and permeability look like. This study is intended to provide early data on whether this approach could become a useful new way to assess barrier dysfunction in IBD.

Conditions

  • Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)
  • NON-IBD

Interventions

DIAGNOSTIC_TEST

Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping

This is an observational study, and participants are not assigned a therapeutic intervention as part of the research. All participants will undergo a clinically indicated colonoscopy as part of routine care. As part of the study procedures, colonoscopy will be supplemented with intravenous sodium fluorescein, wide-field fluorescence imaging during scope withdrawal, and AI-assisted video recording and analysis to assess mucosal permeability. In addition, targeted research biopsies will be collected from selected colonic regions for histologic assessment, and at the McMaster site a subset of biopsies will also undergo ex vivo Ussing chamber permeability testing.

Sponsors & Collaborators

Principal Investigators

  • Premysl Bercik, MD · Hamilton Health Sciences, McMaster University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-02-01
Completion
2027-02-01

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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 NCT07546955 on ClinicalTrials.gov