Efficacy of the Third Eye Retroscope Auxiliary Imaging System
The purpose of this study is to demonstrate efficacy of the Avantis Third Eye Retroscope auxiliary imaging system.
The primary objective of this study is to assess the degree to which incorporating the Third Eye Retroscope auxiliary imaging system in a screening colonoscopy setting results in the detection of additional polyps.
Specifically, the primary goals are to estimate (1) the proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope, and (2) the proportion of patients found under this protocol to have polyps who would have incorrectly been classified as polyp-free had the Third Eye Retroscope not been used.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System|
- Increase (Percent) of Polyps Detected That Would Have Been Missed Without the Third Eye Retroscope (TER) [ Time Frame: Total 30 minutes procedure time with TER use. ] [ Designated as safety issue: No ]After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
- Number Polyps Detected With the Standard Colonoscope and Third Eye Retroscope (TER) [ Time Frame: Total 30 minutes procedure time with TER use. ] [ Designated as safety issue: No ]After cecal intubation, the disposable TER was inserted through the instrument channel of the colonoscope. During withdrawal, the forward and retrograde video images were observed simultaneously on a wide-screen monitor. A 2 year study period was used to collect colonoscopy exam results.
- Number Participants With Polyps Who Would Have Incorrectly Been Classified as Polyp-free Had the Third Eye Retroscope Not Been Used. [ Time Frame: 2 year study period to collect colonoscopy exam results ] [ Designated as safety issue: No ]Colonoscope and TER use where during TER withdrawal forward and retrograde video images observed simultaneously on a wide-screen monitor for purpose of detecting polyps. Colonoscopy procedures completed in approximately 30 minutes total.
|Study Start Date:||March 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Experimental: Third Eye Retroscope
Colonoscopy exam using the Third Eye Retroscope device
Device: Third Eye Retroscope Auxiliary Imaging System
A thin, flexible probe that is inserted in a standard colonoscope in order to display very detailed images of the colon tissue.
THE STUDY DEVICE:
The Third Eye Retroscope is a thin, flexible probe that can be inserted in a standard colonoscope in order to display very detailed images of the colon tissue. It contains a miniature video camera that allows the doctor to see an additional point of view that looks backward while the regular colonoscope and study device are moved together through the length of the colon.
For you to be eligible to take part in this study, your doctor will check to be sure you have no medical conditions that would increase your risk of having any complications as a result of having the study device used during your colonoscopy.
If you are found to be eligible to take part in this study, your doctor will perform your colonoscopy exam in the usual manner except that the Third Eye Retroscope device will be used during the exam as well. Your doctor will insert the colonoscope into your rectum in the usual manner and will then insert the study device down a channel inside the colonoscope. You will sign a separate consent form for the colonoscopy, which will describe the procedure and its risks in more detail.
During the exam, you will be awake. If you have chosen to use medications for conscious sedation, you will be drowsy.
FOLLOW-UP PHONE CALL:
About 48 hours (2 days) after the study procedure, you will be called by the research staff to see how you are doing. After this follow-up call, your participation in this study will be over.
This is an investigational study. The Third Eye Retroscope device is commercially available, but it is not FDA approved for this study's purpose. At this time, for this purpose, it is being used in research only. Up to 700 patients will take part in this study. Up to 100 will be enrolled at M. D. Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00657371
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|El Camino Hospital|
|Mountain View, California, United States, 94040|
|Camino Medical Group Surgi-Center|
|Sunnyvale, California, United States, 94086|
|United States, Indiana|
|Indiana University Medical Center|
|Indianapolis, Indiana, United States, 46202|
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|St. Louis, Missouri, United States, 63130|
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert S. Bresalier, MD||M.D. Anderson Cancer Center|