Effectiveness of Endocuff Vision in Improving ADR

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04395352
• Other study ID #: HREBA.CC-19-0257
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: April 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15816
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Device:
• Endocuff Vision (ECV)
Detachable disposable (single-use) device that fits over the distal colonoscope end.

Locations

Country	Name	City	State
Canada	Forzani and MacPhail Colon Cancer Screening Centre (CCSC)	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients with immediate adverse events	Adverse events occurring at the time of colonoscopy or before discharge, including bleeding or perforation.	Day 1
Secondary	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