Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)NCT07546955
AI-Enhanced Wide-Field Endoscopic Fluorescence Mapping of Gastrointestinal Mucosal Permeability in IBD - A Pilot Study in IBD Patients and Controls
An observational study of Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and NON-IBD, run by Hamilton Health Sciences Corporation.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis), NON-IBD
- What is being tested?
- Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: They will be patients of the Investigator and co-investigators. When the patient comes in for their usual clinical care and/or disease monitoring, the doctor will approach his or her own patients. If the patient is willing to learn more about the research project and provides consent to learn more, the doctor will introduce the patient to the study coordinator.
Who may be able to join
- 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
Who cannot join
- Allergy to fluorescein
- Colorectal cancer
- Advanced polyps or malignant lesions identified during colonoscopy
- Significant cardiopulmonary disease
- Renal failure
- Active infection or sepsis
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Being tested
- Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping
- Keywords
- IBD, CD, UC, Non-IBD
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability MappingDiagnostic 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 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.
| Study group | Role | What they receive |
|---|---|---|
| IBD | Adult patients with established inflammatory bowel disease (ulcerative colitis or Crohn's disease involving the colon) who are undergoing colonoscopy for clinical reasons, will be invited to participate. We will include patients across the spectrum of disease activity (remission to active inflammation) to capture a broad range of mucosal permeability patterns. Approximately 60 IBD participants will be enrolled at the three sites, representing both major IBD subtypes and varying disease distribution Receives: Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping | |
| Non-IBD | An additional 10 non-IBD controls undergoing routine CRC screening or surveillance will be included. Receives: Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Feasibility of Procedure
- Feasibility of Procedure: The proportion of enrolled patients in whom the full fluorescence mapping procedure is successfully completed as intended. This will include metrics such as ability to intubate the colon and obtain fluorescence images from cecum to rectum; any significant technical difficulties encountered (and their nature); additional procedure time added by the imaging (in minutes); and whether the resulting fluorescence data was of analyzable quality. We will define success as achieving a usable permeability map of the colon surface. Feasibility will also be described by qualitative feedback from endoscopists on workflow integration.
Measured: From enrollment to end of study = one patient visit
• Safety of the Imaging System
Incidence and severity of adverse events related to the investigational aspects (fluorescein and AI system). This includes any allergic reactions to fluorescein, any hemodynamic instability during the procedure attributable to the dye, any complications from prolonged procedure time (e.g. hypoxia from sedation), or any device malfunctions leading to patient risk. Adverse events will be categorized as mild, moderate, severe, and their relationship to the study intervention will be adjudicated. The primary safety endpoint is the absence of any Serious Adverse Effect. We hypothesize that the rate of serious complications will be <5%, with the expectation of 0% severe allergic reactions in a 60 patient sample (based on fluorescein's known <1/1000 severe reaction rate). We will specifically report the number of patients with any fluorescein-related reaction (and details if so).
Measured: From enrollment to end of study = one patient visit
Secondary outcomes (5)
• Correlation with Endoscopic Severity:
We will assess whether fluorescence permeability at each biopsy site correlates with endoscopic inflammation in that same anatomical region. Fluorescence metrics (e.g., normalized peak intensity, number of leak foci) from each biopsy site - high-fluorescence and low-fluorescence regions - will be compared with the corresponding local endoscopic severity score (Mayo endoscopic subscore for UC; the segmental SES-CD subscore for CD). Because biopsies are obtained from specific marked locations rather than from every colonic segment, analyses will be performed at the biopsy-site level rather than the segment level. Correlation coefficients (Spearman or Pearson) will quantify the association between fluorescence signal and endoscopic activity. We will also compare mean fluorescence values between biopsy sites taken from endoscopically inflamed vs non-inflamed regions. Controls will typically score as non-inflamed (Mayo = 0; SES-CD = 0).
Measured: From enrollment to end of study = one patient visit
• Correlation with Histopathology
Fluorescence permeability measurements at each biopsy site will be correlated with histologic inflammation scored using disease-appropriate indices (Nancy Index for UC; GHAS for CD and controls). Because each participant provides a paired set of biopsies (one high-fluorescence and one low-fluorescence site from the same anatomical region), comparisons will occur at the biopsy-site level. We will analyze:
- correlation between fluorescence intensity and histology score across all biopsy sites
- differences in histologic scores between high- and low-fluorescence sites within each participant
- exploratory pooled analyses using a unified ordinal inflammation scale Controls are expected to score as non-inflamed on GHAS.
Measured: From enrollment to end of study = one patient visit
• Correlation with Ussing ex vivo permeability (Performed at McMaster only)
For each participant, fluorescence metrics at the specific biopsy sites will be correlated with matched ex vivo ⁵¹Cr-EDTA flux from the same locations. Analyses will again be at the biopsy-site level. Additionally, we will perform within-patient gradient analysis, comparing the difference between high- and low-fluorescence sites:
- Δ fluorescence (high - low)
- Δ Ussing flux (high - low) A positive association between Δ fluorescence and Δ Ussing flux will indicate that higher in vivo leak corresponds to higher physiologic permeability.
Measured: From enrollment to end of study = one patient visit
• Accuracy of AI Detection
Using the initial manual annotations and multidisciplinary review as the reference, we will calculate how accurately the AI algorithm identifies high-permeability regions. Metrics like sensitivity, specificity, and predictive values for AI-detected "leak sites" against human-identified or biopsy-proven inflammation sites will be reported. Including control participants (non-IBD) will help ensure that the AI model correctly identifies normal mucosa as low-permeability, improving specificity.
Measured: From enrollment to end of study = one patient visit
• Inter-Observer Consistency
Although the AI provides an objective measure, we will check consistency by having multiple investigators review a subset of the fluorescence videos independently to mark obvious leak spots. The AI's output will be compared to each reviewer's marks (and reviewers to each other) to ensure the AI reduces inter-observer variability. High agreement would support reproducibility.
Measured: From enrollment to end of study = one patient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Premsyl Bercik, Hamilton Health Sciences Corporation
- Investigators
- Premysl Bercik, MD, Principal investigator, Hamilton Health Sciences, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546955
- Sponsor's protocol ID
- REB 19656
- Status last verified
- Mar 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- REB 19656
- Keywords
- IBD, CD, UC, Non-IBD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBD | – | Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability MappingAdult patients with established inflammatory bowel disease (ulcerative colitis or Crohn's disease involving the colon) who are undergoing colonoscopy for clinical reasons, will be invited to participate. We will include patients across the spectrum of disease activity (remission to active inflammation) to capture a broad range of mucosal permeability patterns. Approximately 60 IBD participants will be enrolled at the three sites, representing both major IBD subtypes and varying disease distribution |
| Non-IBD | – | Diagnostic Test: Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability MappingAn additional 10 non-IBD controls undergoing routine CRC screening or surveillance will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- They will be patients of the Investigator and co-investigators. When the patient comes in for their usual clinical care and/or disease monitoring, the doctor will approach his or her own patients. If the patient is willing to learn more about the research project and provides consent to learn more, the doctor will introduce the patient to the study coordinator.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Allergy to fluorescein
- Colorectal cancer
- Advanced polyps or malignant lesions identified during colonoscopy
- Significant cardiopulmonary disease
- Renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence-Enhanced Wide-Field Mucosal Permeability MappingThis 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. | Diagnostic test | IBD, Non-IBD |
Primary outcome
• Feasibility of Procedure
Time frame: From enrollment to end of study = one patient visit
• Feasibility of Procedure: The proportion of enrolled patients in whom the full fluorescence mapping procedure is successfully completed as intended. This will include metrics such as ability to intubate the colon and obtain fluorescence images from cecum to rectum; any significant technical difficulties encountered (and their nature); additional procedure time added by the imaging (in minutes); and whether the resulting fluorescence data was of analyzable quality. We will define success as achieving a usable permeability map of the colon surface. Feasibility will also be described by qualitative feedback from endoscopists on workflow integration.
• Safety of the Imaging System
Time frame: From enrollment to end of study = one patient visit
Incidence and severity of adverse events related to the investigational aspects (fluorescein and AI system). This includes any allergic reactions to fluorescein, any hemodynamic instability during the procedure attributable to the dye, any complications from prolonged procedure time (e.g. hypoxia from sedation), or any device malfunctions leading to patient risk. Adverse events will be categorized as mild, moderate, severe, and their relationship to the study intervention will be adjudicated. The primary safety endpoint is the absence of any Serious Adverse Effect. We hypothesize that the rate of serious complications will be <5%, with the expectation of 0% severe allergic reactions in a 60 patient sample (based on fluorescein's known <1/1000 severe reaction rate). We will specifically report the number of patients with any fluorescein-related reaction (and details if so).
5 secondary outcomes
• Correlation with Endoscopic Severity:
Time frame: From enrollment to end of study = one patient visit
• Correlation with Histopathology
Time frame: From enrollment to end of study = one patient visit
• Correlation with Ussing ex vivo permeability (Performed at McMaster only)
Time frame: From enrollment to end of study = one patient visit
• Accuracy of AI Detection
Time frame: From enrollment to end of study = one patient visit
• Inter-Observer Consistency
Time frame: From enrollment to end of study = one patient visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Premysl Bercik, MD principal investigator
Hamilton Health Sciences, McMaster University
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease (Crohn's Disease; Ulcerative Colitis) and NON-IBD, run by Hamilton Health Sciences Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liam Rondeau, PhD (905-521-2100 ext. 22060, rondeaul@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Feasibility of Procedure (time frame: From enrollment to end of study = one patient visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.