Effectiveness of Endocuff Vision in Improving ADR

University of Calgary

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Device: Endocuff Vision (ECV)

Study type: Observational

Funder types: Other

Identifiers

NCT04395352

HREBA.CC-19-0257

Details and patient eligibility

About

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.

Enrollment: 15,816 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

15,816 participants in 2 patient groups

Pre-ECV

Description:

Patients having undergone colonoscopy prior to the introduction of ECV (November 1 2018 to April 30 2019).

ECV

Description:

Patients having undergone colonoscopy after the introduction of ECV (June 1 2019 to November 30 2019).

Treatment:

Device: Endocuff Vision (ECV)