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AI-Enhanced Endoscopic Fluorescence Mapping in IBD - 70 Patients, 3 Canadian Sites

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Summary

A new observational pilot study (NCT07546955) will test AI-enhanced fluorescent dye imaging during colonoscopy to measure mucosal permeability in inflammatory bowel disease. The study will enroll 70 adults across 3 Canadian hospitals: 60 with ulcerative colitis or Crohn's disease affecting the colon, and 10 non-IBD controls having routine colonoscopy for colorectal cancer screening. During the procedure, participants receive intravenous fluorescein while the imaging system records fluorescence as the scope is withdrawn.

“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).”

NIH , verbatim from source
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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

This ClinicalTrials.gov registry entry adds a new observational pilot study evaluating AI-enhanced wide-field mucosal permeability mapping in IBD patients using endoscopic fluorescence imaging with intravenous fluorescein dye. The study is sponsored by the NIH and will enroll 70 participants across three Canadian hospital sites.

For clinical research teams and gastroenterologists conducting IBD research, this registry entry signals a new early-phase study investigating a potential novel approach to assessing intestinal barrier dysfunction. The study's ex vivo Ussing chamber validation component at the McMaster site may be of interest to researchers studying mucosal permeability methodologies.

Archived snapshot

Apr 23, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

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

Observational NCT07546955 Kind: OBSERVATIONAL Apr 23, 2026

Abstract

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: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping

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Last updated

Classification

Agency
NIH
Published
April 23rd, 2026
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators Patients
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial enrollment Medical imaging research Inflammatory bowel disease research
Geographic scope
Canada CA

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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