AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls
Observational · No treatment assigned · Sites not listed yet · Hamilton Health Sciences Corporation
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and NON-IBD. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 2 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 70 participants are expected to take part.
- Start date: 2026-04-01 (planned).
- Main results expected around 2027-02-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- • Feasibility of Procedure (From enrollment to end of study = one patient visit)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis); NON-IBD |
| Lead sponsor | Hamilton Health Sciences Corporation |
| Collaborators | McMaster University |
| Enrollment | 70 (estimated) |
| Start date | 2026-04-01 |
| Primary completion (est.) | 2027-02-01 |
| First posted | 2026-04-23 |
| Last updated | 2026-04-23 |
| Official title | AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls |
| ClinicalTrials.gov ID | NCT07546955 |
Interventions
- Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping (Diagnostic Test)
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 …
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * Allergy to fluorescein * Colorectal cancer * Advanced polyps or malignant lesions identified during colonoscopy * Significant cardiopulmonary disease * Renal failure * Active infection or sepsis * Severe IBD flare * Use of medications that may affect gut permeability, including NSAIDs or antibiotics * 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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.