An observational study in Polyp of Colon and Crohn Disease, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Observational
The goal of this prospective observational study is to assess the accuracy and reliability of laser readings obtained through AccuMeasure, in comparison to other measurements performed by gastroenterologists. AccuMeasure is a novel technology, that has emerged as a promising tool for measuring polyps and lesions during colonoscopies. The system employs laser-based measurements, enabling precise determination of lesion size, depth, and extent. The main hypotheses this study aims to evaluate are:
Data will be gathered during standard of care endoscopies conducted at CHUM by board-certified gastroenterologists or supervised trainees. Patients will undergo preparation based on the latest guidelines, receive sedation according to clinical standards, and undergo clinical decision and surveillance following standard of care, unaffected by study participation.
An initial visual estimation of lesion size will be performed by endoscopists without instruments, relying on their visual assessment of the intestinal lining for signs of inflammation, ulceration, strictures, or abnormalities during colonoscopy. Subsequently, the AccuMeasure will be employed for lesion size measurement. AccuMeasure sizes will be obtained for six groups of lesions: (1) ulcer size in patients with Crohn's disease or ulcerative colitis, (2) Ulcerative Colitis related lesions, (3) polyps, (4) non-IBD ulcers and erosions and inflammatory lesions, (5) Barrett's and associated lesions, and (6) other GI lesions will be measured.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 411 across 115 observational studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All eligible patients presenting at the CHUM for an endoscopy will be approached for this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Validity of AccuMeasure when measuring ulcer size in patients with Crohn's disease or ulcerative colitis
The validity of AccuMeasure measurements of ulcer size in patients with Crohn's disease or ulcerative colitis is assessed through a correlation coefficient of ≥0.7 between AccuMeasure measurements and traditional scoring methods (SES-CD, CDEIS, mayo endoscopic score), symptomatic remission (CD PRO2 \< 8, partial mayo score), and fecal calprotectin levels
Time frame: During the endoscopy
Reliability of AccuMeasure when measuring ulcer size in patients with Crohn's disease or ulcerative colitis
The reliability of AccuMeasure measurements for ulcer size in patients with Crohn's disease or ulcerative colitis is assessed through an Intraclass Correlation Coefficient (ICC) of ≥0.8, that ensures consistent measurements intra- and inter- different raters
Time frame: During the endoscopy
Correlation between AccuMeasure and Endoscopic Disease Activity when measuring ulcer size in patients with Crohn's disease or ulcerative colitis
An equivalence test between Endoscopic Disease Activity (visual analogue scale, 100-point scale) and AccuMeasure measurements for ulcer size in patients with Crohn's disease or ulcerative colitis will determine this correlation
Time frame: During the endoscopy
Relative Inaccuracy of Visual Estimation Compared to AccuMeasure (Laser-Based Device) for Ulcer Size in Patients with Crohn's Disease or Ulcerative Colitis
A single outcome is reported: the relative inaccuracy (%) of visual estimation compared to AccuMeasure. This outcome is calculated from two measurements taken during the same endoscopy - the visual estimation value and the AccuMeasure value - combined using the following formula: Relative inaccuracy (%) = \|Visual estimation value - AccuMeasure value\| / AccuMeasure value × 100 A superiority z-test will compare this relative inaccuracy against the 9% threshold to assess whether AccuMeasure is superior to visual estimation. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Snare-Based Measurement Compared to AccuMeasure for Ulcer Size in Patients with Crohn's Disease or Ulcerative Colitis
Ulcer size will be measured using AccuMeasure (laser-based device, reference method) and using size estimation using the snare tip as a visual reference, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Snare-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 9% threshold will assess whether AccuMeasure is superior in accuracy. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Forceps-Based Measurement Compared to AccuMeasure for Ulcer Size Measurement in Patients with Crohn's Disease or Ulcerative Colitis
Ulcer size will be measured using AccuMeasure (laser-based device, reference method) and using size estimation using forceps as a visual reference, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Forceps-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 9% threshold will assess whether AccuMeasure is superior in accuracy. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of AI-Based Measurement Compared to AccuMeasure for Ulcer Size Measurement in Patients with Crohn's Disease or Ulcerative Colitis
Ulcer size will be measured using AccuMeasure (laser-based device, reference method) and using an AI model analyzing lesion size from images/videos obtained during the procedure, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|AI-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 9% threshold will assess whether AccuMeasure is superior in accuracy. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Change in AccuMeasure (Laser-Based Device)-Measured Ulcer Size Between Baseline and Follow-Up Endoscopy in Patients with Inflammatory Bowel Disease
A single outcome is reported: the change in ulcer size (mm), measured using AccuMeasure (laser-based measurement device), between an initial endoscopy and a subsequent follow-up endoscopy performed after a change in medical management (e.g., medication change). The change will be compared using paired t-tests or Wilcoxon signed-rank tests, to assess whether AccuMeasure measurements are responsive to changes in disease activity over time. Unit of Measure : Millimeters (mm), change from baseline
Time frame: From baseline endoscopy to follow-up endoscopy, up to 2 years
Correlation Between AccuMeasure (Laser-Based Device)-Measured Ulcer Size and Occurrence of Medication Escalation in Patients with Inflammatory Bowel Disease
Correlation between two measures assessed at/after the index endoscopy: Ulcer size (mm), measured using AccuMeasure (laser-based measurement device) at the index endoscopy. Occurrence of a medication change/escalation in disease management (yes/no), assessed via medical record review, occurring in the 6 to 12 months following the index endoscopy. Unit of Measure : Correlation coefficient (AccuMeasure ulcer size in mm vs. occurrence of medication escalation, yes/no)
Time frame: 6 to 12 months after the index endoscopy
Correlation Between AccuMeasure (Laser-Based Device)-Measured Ulcer Size and Occurrence of Disease-Related Complications in Patients with Inflammatory Bowel Disease
Correlation between two measures: Ulcer size (mm), measured using AccuMeasure (laser-based measurement device) at the index endoscopy. Occurrence of a disease-related complication (yes/no), assessed via medical record review, occurring in the 6 to 12 months following the index endoscopy. Unit of Measure : Correlation coefficient (AccuMeasure ulcer size in mm vs. occurrence of disease-related complication, yes/no)
Time frame: 6 to 12 months after the index endoscopy
Association Between AccuMeasure-Measured Ulcer Size and Hospitalization in Patients with Inflammatory Bowel Disease
Correlation between AccuMeasure-measured ulcer size (in mm) at the index endoscopy and occurrence of hospitalization related to inflammatory bowel disease, occurring in the 6 to 12 months following the index endoscopy. Unit of Measure : Correlation coefficient (AccuMeasure size in mm vs. occurrence of outcome)
Time frame: 6 to 12 months after the index endoscopy
Relative Inaccuracy of Visual Estimation Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement
For ulcerative colitis-related lesions, size will be measured using AccuMeasure (laser-based device, reference method) and using unaided visual estimation by the endoscopist, without instruments, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Visual Estimation value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Snare-Based Measurement Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement
For ulcerative colitis-related lesions, size will be measured using AccuMeasure (laser-based device, reference method) and using size estimation using the snare tip as a visual reference, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Snare-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Forceps-Based Measurement Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement
For ulcerative colitis-related lesions, size will be measured using AccuMeasure (laser-based device, reference method) and using size estimation using forceps as a visual reference, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Forceps-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of AI-Based Measurement Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement
For ulcerative colitis-related lesions, size will be measured using AccuMeasure (laser-based device, reference method) and using an AI model analyzing lesion size from images/videos obtained during the procedure, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|AI-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Visual Estimation Compared to AccuMeasure for Polyps Size Measurement
For polyps, size will be measured using AccuMeasure (laser-based device, reference method) and using unaided visual estimation by the endoscopist, without instruments, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Visual Estimation value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Snare-Based Measurement Compared to AccuMeasure for Polyps Size Measurement
For polyps, size will be measured using AccuMeasure (laser-based device, reference method) and using size estimation using the snare tip as a visual reference, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Snare-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Relative Inaccuracy of Forceps-Based Measurement Compared to AccuMeasure for Polyps Size Measurement
For polyps, size will be measured using AccuMeasure (laser-based device, reference method) and using size estimation using forceps as a visual reference, during the same endoscopic procedure. Relative inaccuracy will be calculated as: \|Forceps-Based Measurement value - AccuMeasure value\| / AccuMeasure value, expressed as a percentage. A superiority z-test against a 10% threshold will assess whether AccuMeasure is superior in accuracy for this lesion group. Unit of Measure : Percentage of relative inaccuracy (%)
Time frame: During the endoscopy
Plan to share: Yes — Individual participant data that underlie the results reported in research articles based on this study, after de-identification (text, tables, figures and appendices).
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for May 2027, 24 months after the start.
Of 52 non-industry observational studies under Colonic Polyps, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 90. This study's planned 24 months is above that.
Counting every sponsor, half of 62 studies reached it within 19 months; a quarter within 10 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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