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NCT Number: NCT07770425

Lesion Size Measurement During Gastrointestinal Endoscopies

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.

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Key information

Conditions

Polyp of Colon Colonic Polyps Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location status: Recruiting

Location contact

Daniel von Renteln, MD, PhD

PRINCIPAL_INVESTIGATOR

Samira Hanin

CONTACT

[email protected]

514-890-8000 ext. 30916

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Validity of AccuMeasure when measuring ulcer size in patients with Crohn's disease or ulcerative colitis

    Time frame: During the endoscopy

    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

  2. Reliability of AccuMeasure when measuring ulcer size in patients with Crohn's disease or ulcerative colitis

    Time frame: During the endoscopy

    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

  3. Correlation between AccuMeasure and Endoscopic Disease Activity when measuring ulcer size in patients with Crohn's disease or ulcerative colitis

    Time frame: During the endoscopy

    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

  4. Relative Inaccuracy of Visual Estimation Compared to AccuMeasure (Laser-Based Device) for Ulcer Size in Patients with Crohn's Disease or Ulcerative Colitis

    Time frame: During the endoscopy

    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 (%)

  5. Relative Inaccuracy of Snare-Based Measurement Compared to AccuMeasure for Ulcer Size in Patients with Crohn's Disease or Ulcerative Colitis

    Time frame: During the endoscopy

    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 (%)

  6. Relative Inaccuracy of Forceps-Based Measurement Compared to AccuMeasure for Ulcer Size Measurement in Patients with Crohn's Disease or Ulcerative Colitis

    Time frame: During the endoscopy

    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 (%)

  7. Relative Inaccuracy of AI-Based Measurement Compared to AccuMeasure for Ulcer Size Measurement in Patients with Crohn's Disease or Ulcerative Colitis

    Time frame: During the endoscopy

    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 (%)

Secondary outcomes

  1. Change in AccuMeasure (Laser-Based Device)-Measured Ulcer Size Between Baseline and Follow-Up Endoscopy in Patients with Inflammatory Bowel Disease

    Time frame: From baseline endoscopy to follow-up endoscopy, up to 2 years

    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

  2. Correlation Between AccuMeasure (Laser-Based Device)-Measured Ulcer Size and Occurrence of Medication Escalation in Patients with Inflammatory Bowel Disease

    Time frame: 6 to 12 months after the index endoscopy

    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)

  3. Correlation Between AccuMeasure (Laser-Based Device)-Measured Ulcer Size and Occurrence of Disease-Related Complications in Patients with Inflammatory Bowel Disease

    Time frame: 6 to 12 months after the index endoscopy

    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)

  4. Association Between AccuMeasure-Measured Ulcer Size and Hospitalization in Patients with Inflammatory Bowel Disease

    Time frame: 6 to 12 months after the index endoscopy

    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)

  5. Relative Inaccuracy of Visual Estimation Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement

    Time frame: During the endoscopy

    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 (%)

  6. Relative Inaccuracy of Snare-Based Measurement Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement

    Time frame: During the endoscopy

    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 (%)

  7. Relative Inaccuracy of Forceps-Based Measurement Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement

    Time frame: During the endoscopy

    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 (%)

  8. Relative Inaccuracy of AI-Based Measurement Compared to AccuMeasure for Ulcerative Colitis-Related Lesions Size Measurement

    Time frame: During the endoscopy

    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 (%)

  9. Relative Inaccuracy of Visual Estimation Compared to AccuMeasure for Polyps Size Measurement

    Time frame: During the endoscopy

    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 (%)

  10. Relative Inaccuracy of Snare-Based Measurement Compared to AccuMeasure for Polyps Size Measurement

    Time frame: During the endoscopy

    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 (%)

  11. Relative Inaccuracy of Forceps-Based Measurement Compared to AccuMeasure for Polyps Size Measurement

    Time frame: During the endoscopy

    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 (%)

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Registry information

Acronym: AccuMeasure

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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