Effectiveness of Endocuff Vision in Improving ADR

Study Overview
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Brief Summary
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The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.

Official Title
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Effectiveness of EndoCuff Vision in Improving Adenoma Detection Rate in a Large Screening-Related Cohort

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Device: Endocuff Vision (ECV)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients undergoing colonoscopy. Exclusion Criteria: single balloon- or double balloon-assisted colonoscopy; planned advanced polypectomy or endoscopic mucosal resection (EMR); planned endoscopic post-polypectomy or post-EMR surveillance; known active diverticulitis; known colonic stricture.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-ECV<br>Patients having undergone colonoscopy prior to the introduction of ECV (November 1 2018 to April 30 2019). | |
| ECV<br>Patients having undergone colonoscopy after the introduction of ECV (June 1 2019 to November 30 2019). | Device: Endocuff Vision (ECV)<br>* Detachable disposable (single-use) device that fits over the distal colonoscope end.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) | Proportion of an endoscopist's screening-related colonoscopies during which one or more adenoma was biopsied or removed | Intra-procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate among patients with positive fecal immunochemical tests | Proportion of an endoscopist's colonoscopies performed for +fecal immunochemical test (FIT), or indications other than positive FIT during which one or more adenoma was biopsied or removed. In order to be included in the non-FIT ADR category, a patient must not have undergone a colonoscopy at CCSC within the last four years of the index procedure. | Intra-procedural | 
| SSADR (sessile serrated adenoma detection rate) | Proportion of an endoscopist's screening-related colonoscopies during which one or more sessile serrated adenoma was biopsied or removed | Intra-procedural | 
| CIR (cecal intubation rate) | Proportion of an endoscopist's screening-related procedures in which the cecal pole is intubated, as landmarked by direct visualization of the appendiceal orifice, ileocecal valve, or both. | Intra-procedural | 
| Procedure time | Total time spent by an endoscopist from the start of the colonoscopy procedure (insertion of the colonoscope through the anus) to the end of the colonoscopy (removal of the colonoscope from the anus). This variable will be calculated only for cases in which no pathology was encountered. | Intra-procedural | 
| Nurse-assessed patient comfort scores (NAPCOMs) | Validated score for determining patients' procedural comfort. Scored from 0 to 9, with higher scores indicating higher discomfort intensity, frequency, and/or duration. | Intra-procedural | 
| Number of patients with immediate adverse events | Adverse events occurring at the time of colonoscopy or before discharge, including bleeding or perforation. | Day 1 | 
| Number of patients with delayed adverse events | Adverse events within 30 days of the index procedure, including delayed bleeding, delayed perforation, or acute healthcare utilization (emergency department visit or hospital admission) for any other reasons deemed related to index colonoscopy. | Within 30 days of index procedure |