Detection and Classification of Colon Polyps

NCT00825292 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2009-01-21

No results posted yet for this study

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.

Conditions

  • Colon Polyps

Interventions

PROCEDURE

Polp removal and identification

Identify polyp during colonoscopy then remove polyp

PROCEDURE

colon polyp removal

identify and remove polyp

PROCEDURE

ETMI colonoscope (ETMI scope is a FDA approved device)

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

Sponsors & Collaborators

Principal Investigators

  • Seth A. Gross, M.D. · Mayo Clinic

  • Michael B. Wallace, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00825292 on ClinicalTrials.gov