Comparison of Two Devices During Colonoscopy

Status Completed

Clinical Trial Summary

Clinical Trial Description

Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology and colorectal cancer screening. Adenoma detection rate is a marker of high quality colonoscopy and a high adenoma detection rate is associated with a lower incidence of interval cancers. Several technological advancements have been explored to improve adenoma detection rate. Endocuff Vision™ has been shown to improve adenoma detection rate in several studies. Cap-assisted colonoscopy is a technique that allow improved visualization of the colonic folds by flattening the fold within the viewing field. However, studies have reported mixed results on adenoma detection in cap-assisted colonoscopy.

This is a prospective, single-centre, randomized controlled trial comparing the adenoma detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy versus cap-assisted colonoscopy. Patients are randomized according to bowel cancer screening status to receive Endocuff Vision™-assisted colonoscopy or cap colonoscopy on the day of procedure. Baseline data, colonoscopy, and polyp data including histology are collected. Patients are followed up at 30 days for complications. This study will take place in an University Hospital in Spain. A maximum of 9 expert colonoscopists will recruit a total of 712 patients.

This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™ vs cap colonoscopy in all screening, surveillance, and diagnostic patient groups. This study will guide clinicians to decide what device to use to increase adenoma detection rate in routine colonoscopy ;

Study Design

Related Conditions & MeSH terms

Adenomatous Polyps

Clinical Trial Details

NCT number	NCT03197987
Study type	Interventional
Source	Hospital General Universitario Elche
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2017
Completion date	July 31, 2018

View Details

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Comparison of Two Devices During Colonoscopy — COLONAUX

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms