Colorectal Neoplasms Clinical Trial
Official title:
Third Eye Panoramic Device Feasibility Evaluation
This study will evaluate the feasibility of using the Third Eye Panoramic device in
conjunction with standard colonoscopes in a clinical setting.
Patients will undergo a colonoscopy procedure during which the study device will provide
video imaging of areas of the colon that are difficult to evaluate with the colonoscope
alone.
The utility of the device will be assessed from the impressions of the investigators and
from telephone follow-up with subjects to assess for post-procedural complications.
The purpose of this study is to evaluate the feasibility of using the Third Eye Panoramic
device along with a standard colonoscope as a means of enhancing the ability of endoscopists
to view areas that are hidden from the view of the colonoscope.
Colonoscopy is generally agreed to be the best method for detecting and removing cancers and
pre-cancerous adenomas in the colon. However, numerous studies have demonstrated that from
22% to over 40% of adenomas are missed during standard colonoscopy. More importantly, 12% of
large adenomas (at least 1 cm) are missed even by expert endoscopists using meticulous
technique with the best available equipment, and these large adenomas are the ones that are
most likely to transform into cancer.
Factors such as quality of bowel cleansing and time spent examining the colonic mucosa have
been shown to affect miss rates. However, comparison with the results of CT colonography has
shown that 2/3 of missed adenomas are located behind folds in the wall of the colon, in
areas that are very difficult to see with a standard forward-viewing colonoscope.
When clipped onto the tip of a standard colonoscope, the Third Eye Panoramic device provides
two additional miniature video cameras and light sources that offer views to the left side
and right side of the colonoscope's tip. These lateral views complement the forward view of
the colonoscope's camera to result in a "panoramic" view of over 300°. This extreme
wide-angle view allows the endoscopist to examine the areas located behind folds.
In this study, each subject will undergo a colonoscopy procedure utilizing the Third Eye
Panoramic device along with a standard colonoscope.
The investigators will evaluate issues related to usability and safety based on their
experience and impressions, with telephone follow-up with subjects to assess for any
post-procedural complications.
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