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NCT07546955Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 23 Apr 2026

Brief summary (registry, in English)

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will receive intravenous fluorescein, and the imaging system will record fluorescence in the colon as the scope is withdrawn.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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
70 (estimated)
First submitted
17 Apr 2026
Start date
1 Apr 2026
Primary completion date
1 Feb 2027
Lead sponsor
Hamilton Health Sciences Corporation
NCT number
NCT07546955

What you commit to

  • Study type: Observational
  • Planned participants: 70
  • From 1 Apr 2026 to the primary completion date, 1 Feb 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

  • Use of medications that may affect gut permeability, including NSAIDs or antibiotics

Other illness

  • Allergy to fluorescein
  • Colorectal cancer
  • Advanced polyps or malignant lesions identified during colonoscopy
  • Significant cardiopulmonary disease
  • Renal failure
  • Active infection or sepsis

Other

  • Severe IBD flare
  • Inability to tolerate bowel preparation or safely complete the protocol
  • Pregnancy or breastfeeding
  • Inability or unwillingness to provide informed consent or comply with study procedures

Who the study is looking for

  • Adults aged 18 years or older
  • Able to provide written informed consent
  • Established ulcerative colitis or Crohn's disease involving the colon, or non-IBD control undergoing screening/surveillance colonoscopy
  • Undergoing clinically indicated colonoscopy
  • Ability to comply with study procedures

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.