Lesion Size Measurement During Gastrointestinal Endoscopies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients (18 years and older)
Patients undergoing gastrointestinal endoscopy procedures
Disqualifiers
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 population
All eligible patients presenting at the CHUM for an endoscopy will be approached for this study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
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
Time frame
During the endoscopy2
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 endoscopy3
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 endoscopy4
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 endoscopySecondary outcomes
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
Time frame
From baseline endoscopy to follow-up endoscopy, up to 2 years2
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 endoscopy3
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 endoscopy4
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 endoscopySponsors and contacts
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Source ClinicalTrials.gov