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Polyp of ColonAccuMeasureNCT07770425

Lesion Size Measurement During Gastrointestinal Endoscopies

An observational study of Polyp of Colon and Crohn Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polyp of Colon, Crohn Disease
How many people
3,000 participants
Where
1 siteCanada
Study dates
9 May 2025to Nov 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: All eligible patients presenting at the CHUM for an endoscopy will be approached for this study.

Who may be able to join

  • Adult patients (18 years and older)
  • Patients undergoing gastrointestinal endoscopy procedures

Who cannot join

  • Minors: Patients under 18 years of age.
  • Patients who do not provide informed consent.
  • Patients undergoing endoscopy on an emergency basis (defined as urgent diagnostic or therapeutic endoscopy performed on the gastrointestinal (GI) tract to address potentially life-threatening conditions or severe symptoms that require immediate medical attention).
  • An American Society of Anesthesiologists (ASA) physical status classification greater than 3.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec

    Samira Hanin, 514-890-8000 ext. 30916, samira.hanin.chum@ssss.gouv.qc.ca

    Daniel von Renteln, MD, PhD

    Recruiting

Other trials in Canada

About this study

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:

  • AccuMeasure technology, with its precise laser measurements, will demonstrate superior accuracy and reliability in assessing lesion size of pathologies encountered during endoscopies, when compared to other endoscopic scoring methods.
  • AccuMeasure measurements will show strong construct validity by correlating significantly with endoscopic subscores, symptomatic remission (CD PRO2 <8, partial mayo score), and fecal calprotectin values.
Read the detailed description

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.

Medical subject headings
Colonic Polyps, Crohn Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: During the endoscopy

  2. 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

    Measured: During the endoscopy

  3. 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

    Measured: During the endoscopy

  4. 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 (%)

    Measured: During the endoscopy

  5. 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 (%)

    Measured: During the endoscopy

  6. 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 (%)

    Measured: During the endoscopy

  7. 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 (%)

    Measured: During the endoscopy

Secondary outcomes (11)
  1. 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

    Measured: From baseline endoscopy to follow-up endoscopy, up to 2 years

  2. 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)

    Measured: 6 to 12 months after the index endoscopy

  3. 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)

    Measured: 6 to 12 months after the index endoscopy

  4. 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)

    Measured: 6 to 12 months after the index endoscopy

  5. 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 (%)

    Measured: During the endoscopy

  6. 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 (%)

    Measured: During the endoscopy

  7. 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 (%)

    Measured: During the endoscopy

  8. 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 (%)

    Measured: During the endoscopy

  9. 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 (%)

    Measured: During the endoscopy

  10. 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 (%)

    Measured: During the endoscopy

  11. 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 (%)

    Measured: During the endoscopy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2026
  2. Study start9 May 2025
  3. Primary completionMay 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07770425
Sponsor's protocol ID
2025-12337
Other IDs
2025
Acronym
AccuMeasure
Status last verified
Nov 2025
First submitted
17 Nov 2025
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in research articles based on this study, after de-identification (text, tables, figures and appendices).

Questions about this trial

What is this clinical trial studying?

An observational study of Polyp of Colon and Crohn Disease, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validity of AccuMeasure when measuring ulcer size in patients with Crohn's disease or ulcerative colitis (time frame: During the endoscopy). The study lists 7 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 18 Aug 2026.

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