A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System
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
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Proportion of polyps detected under this protocol that would have been missed without the Third Eye Retroscope
2 year study period to collect colonoscopy exam results
Robert S. Bresalier, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|El Camino Hospital||Mountain View, California 94040|
|Indiana University Medical Center||Indianapolis, Indiana 46202|
|Washington University||St. Louis, Missouri 63110|
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|
|Mayo Clinic||Scottsdale, Arizona|
|Camino Medical Group Surgi-Center||Sunnyvale, California 94086|