CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,148 enrolled
Drug / intervention
Colonoscopy Capdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01935180
NCT01935180N/ACompleted

Does Cap Assisted Colonoscopy Improve Detection of Adenomatous Polyps? (CAP Trial)

White River Junction Veterans Affairs Medical Center·interventional·Posted Sep 4, 2013·Updated Sep 25, 2018

In Brief

A clinical study evaluating Colonoscopy Cap for Adenomatous Polyps. Completed, enrolled 1,148 participants across 2 sites.

Detailed Summary

Effectiveness of screening colonoscopy in cancer prevention relies on the detection and removal of adenomatous polyps. However, a substantial rate of adenomas is missed during a colonoscopy. It has been estimated that two thirds of missed adenomas are located on the proximal aspect of colonic folds. Attaching a transparent cap to the tip of a colonoscope may allow examination of the proximal aspect of colonic folds, and some early studies have suggested an increased polyp and adenoma detection using this technology. However, the studies have in part substantial methodological limitations (e.g. missing polyp histology, single endoscopist study, polyps not removed at the time of detection). Therefore, at this point it is unclear whether cap assisted colonoscopy may improve adenoma detection. The objective of this study is to evaluate whether cap assisted colonoscopy improves adenoma detection. The investigators propose a two-center multiple endoscopists randomized controlled trial. Patients will be randomized to cap assisted colonoscopy or standard high definition white light colonoscopy. The cap is a 4mm commercially available transparent cap that is attached to the tip of the colonoscopy. Primary outcome measure is the adenoma detection rate (mean number of adenoma per patient). The investigators will assess and adjust for possible variables that can affect adenoma detection, including withdrawal time and quality of colon preparation. As a secondary outcome of interest the investigators will evaluate a possible learning curve effect among all endoscopists (a minimum of six) new to this method. In addition the investigators will evaluate whether cap assisted endoscopy improves real time prediction of polyp histology.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 4, 2013
Enrollment StartDec 1, 2010
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.8 years ago

Interventions

Colonoscopy Capdevice

4mm transparent cap (Olympus) mounted to the tip of a colonoscope.