Avantis Medical Systems has announced that positive results from a clinical study of its Third Eye Retroscope were presented at the American College of Gastroenterology (ACG) 2011 Annual Scientific Meeting. The device is an attachment to a conventional colonoscope that provides a rear view (forgive the pun) in addition to the standard forward facing camera.
The study showed a statistically significant improvement in the detection of adenomas using the retroscope compared to traditional colonoscopy.
After looking at a number of other variables such as age, gender, quality of the bowel preparation and time spent examining the colon, they determined that the only variable that showed significant influence on the advantage provided by the Third Eye Retroscope was the indication for the procedure, i.e., the reason why the patient was having the colonoscopy. For patients who were undergoing colonoscopy for “surveillance” after previous removal of adenomas, the additional adenoma detection rate for Third Eye colonoscopy compared to standard colonoscopy was 35.7%. For patients having a “diagnostic” colonoscopy to look for a reason for symptoms such as anemia, weight loss, changes in bowel habits or rectal bleeding, the additional adenoma detection rate with Third Eye colonoscopy was 55.4%. The pooled results for these two “high risk” groups showed a 40.7% additional detection rate with Third Eye colonoscopy.
The subset analysis was performed on results from the Third Eye Retroscope Randomized Clinical Evaluation (TERRACE), a randomized, controlled trial that provided the first head-to-head comparison between standard colonoscopy and Third Eye colonoscopy. Working at four sites in Europe and five in the U.S., the investigators performed two complete colonoscopy exams on each subject — one with and one without the Third Eye Retroscope. In an article published earlier this year in the journal, Gastrointestinal Endoscopy, they had reported the overall results of the study, which showed that with Third Eye colonoscopy they detected 23.2% additional pre-cancerous adenomas that had been missed with standard colonoscopy.(ii)