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Sponsors and Collaborators: |
M.D. Anderson Cancer Center Avantis Medical Systems |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00657371 |
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.
Condition | Intervention |
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Colorectal Cancer |
Device: Third Eye Retroscope Auxiliary Imaging System |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Prospective Efficacy Evaluation of the Third Eye Retroscope Auxiliary Imaging System |
Estimated Enrollment: | 700 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Colonoscopy exam using the Third Eye Retroscope device
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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.
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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.
STUDY PROCEDURES:
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.
Ages Eligible for Study: | 50 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert S. Bresalier, MD | 713-794-5073 |
United States, Arizona | |
Mayo Clinic | Recruiting |
Scottsdale, Arizona, United States, 85259 | |
United States, California | |
Camino Medical Group Surgi-Center | Recruiting |
Sunnyvale, California, United States, 94086 | |
El Camino Hospital | Recruiting |
Mountain View, California, United States, 94040 | |
United States, Indiana | |
Indiana University Medical Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
United States, Missouri | |
Washington University | Recruiting |
St. Louis, Missouri, United States, 63130 | |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Robert S. Bresalier, MD |
Principal Investigator: | Robert S. Bresalier, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Robert S. Bresalier, MD/Professor ) |
Study ID Numbers: | 2007-0246 |
Study First Received: | April 8, 2008 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00657371 |
Health Authority: | United States: Institutional Review Board |
Colorectal Cancer Colonoscopy Third Eye Retroscope Third Eye Retroscope Auxiliary Imaging System Polypectomy |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |