Trial Information

Impact of Experience With the Third Eye Retroscope on Detection Rates and Withdrawal Times During Colonoscopy

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.