Effectiveness of Endocuff Vision in Improving ADR

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms
• Intervention / Treatment: Device: Endocuff Vision (ECV)

• Study Type: Observational
• Enrollment (Actual): 15816

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Forzani and MacPhail Colon Cancer Screening Centre (CCSC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing screening-related colonoscopy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Calgary

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: April 28, 2020
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 20, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: HREBA.CC-19-0257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No