CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Polp removal and identification +2 moreprocedure
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/NCT00825292
NCT00825292Phase 2Completed

Detection and Classification of Colon Polyps: A Comparison of High Definition White Light and Narrow Band Imaging (Endoscopic Trimodal Imaging; ETMI)

Mayo Clinic·interventional·Posted Jan 21, 2009·Updated Jan 21, 2009

In Brief

A Phase 2 clinical trial evaluating Polp removal and identification, colon polyp removal, and 1 other intervention for Colon Polyps. Completed, enrolled 110 participants across 1 site.

Detailed Summary

Colon cancer is the third most common cancer in western society. To prevent colon cancer it is recommended for people to undergo a screening colonoscopy at the age of fifty. The purpose of the colonoscopy is to remove polyps, since some of these lesions are precancerous. Precancerous polyps are called adenomas. This method of prevention is effective, but the standard colonoscopy currently used does not detect all polyps. Studies have reported a polyp miss rate of about 24%. Furthermore, we are unable to distinguish precancerous polyps from benign polyps, also known as hyperplastic polyps, with standard colonoscopy. This results in all polyps being removed at time of colonoscopy, even the benign polyps. To help improve the detection of colon polyps new endoscopic technologies have been developed. These technologies include high definition white light (HDWL)and high definition narrow band imaging (HDNBI). HDWL improves the overall resolution of the images seen during colonoscopy. HDNBI can help us better classify polyps by enhancing their tissue appearance as well as seeing small blood vessels and capillaries. The goal of this study to determine if HDNBI imaging shows an increased polyp detection rate when compared to the current standard colonoscopy. In addition to develop a classification system to help better differentiate between precancerous polyps and their benign counterparts using HDWL and HDNBI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColon Polyps
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 21, 2009
Enrollment StartJul 1, 2006
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 17.4 years ago

Interventions

Polp removal and identificationprocedure

Identify polyp during colonoscopy then remove polyp

colon polyp removalprocedure

identify and remove polyp

ETMI colonoscope (ETMI scope is a FDA approved device)procedure

ETMI colonoscope used to identify colon polyps as compared to HD white light colonoscope identifying colon polyps.