Impact of Experience on Results With the Third Eye Retroscope
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00969124|
Recruitment Status : Completed
First Posted : September 1, 2009
Results First Posted : July 26, 2017
Last Update Posted : July 26, 2017
The Third Eye Retroscope is a device that can be used with a colonoscope to improve the ability of a physician to see areas of the colon that may be hidden from the view of the colonoscope.
Previous studies have shown that physicians are able to detect additional polyps when they use the device along with the colonoscope. The purpose of this study is to determine whether physicians can detect greater numbers of additional polyps as they gain in experience with the device.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Device: Third Eye Retroscope||Not Applicable|
Purpose: This study is intended to determine characteristics of the "learning curve" for use of the Third Eye Retroscope during colonoscopy, both in terms of efficacy for detection of abnormalities in the colon and time-efficiency for endoscopists
Device Description: The Third Eye Retroscope is an auxiliary imaging device that is designed to allow visualization of "hidden areas" during colonoscopy by providing an additional, retrograde view that complements the forward view of the colonoscope.
After a standard colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As it emerges from the distal tip of the colonoscope, the Third Eye Retroscope automatically bends 180 degrees to form a "J" shape. Its sensor then provides a continuous retrograde view of the colon throughout the process of withdrawal of the colonoscope.
The retrograde view assists the endoscopist in visualizing the proximal aspect of haustral folds and rectal valves, as well as the areas behind flexures and the ileocecal valve. With this additional point-of-view, the endoscopist may be able to detect lesions that can be missed by the forward-viewing colonoscope.
Study Design: Patients who are scheduled for colonoscopy will be recruited to the study and examined with the Third Eye Retroscope in conjunction with a standard colonoscope. For each polyp that is found, the endoscopist will indicate whether it could be seen with the colonoscope, or if it could be found with the colonoscope only because it was first detected with the Third Eye.
Each investigator will perform colonoscopies on 20 patients, who will be segmented into four quartiles according to the order of their procedures. Mean results for the quartiles will be compared in order to evaluate the learning curve for Third Eye colonoscopy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||328 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2009|
Experimental: Third Eye Retroscope
All subjects underwent the same intervention, consisting of examination of the colon using a colonoscope along with the Third Eye Retroscope device, with removal of any polyps that were detected during the procedure.
Device: Third Eye Retroscope
Third Eye Retroscope is used in conjunction with a standard colonoscope while performing colonoscopy
- Detection Rates for Adenomas [ Time Frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes) ]Adenomas detected with the colonoscope alone vs. with the Retroscope
- Detection Rates for All Polyps [ Time Frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes) ]All polyps detected with the colonoscope alone vs. with the Retroscope
- Time Spent During Withdrawal Phase and Total Procedure [ Time Frame: During the colonoscopy procedure (up to 1 hour, average 25 minutes) ]Time in minutes for withdrawal phase of procedure and for total procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969124
|United States, Florida|
|Celebration, Florida, United States, 34747|
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|NorthShore University HealthSystem|
|Evanston, Illinois, United States, 60201|
|United States, Massachusetts|
|University of Massachusetts|
|Worcester, Massachusetts, United States, 01655|
|United States, Minnesota|
|Hennepin County Medical Center|
|Minneapolis, Minnesota, United States, 55415|
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|S.W. Fort Worth Endoscopy Center|
|Fort Worth, Texas, United States, 76132|
|North Hills Hospital|
|North Richland Hills, Texas, United States, 76180|
|Principal Investigator:||Daniel C DeMarco, MD||Baylor Health Care System|