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News

New medical device improves polyp detection in the colon

Avantis Medical Systems : 22 May, 2008  (New Product)
Gastroenterologist Jerome D Waye, MD has presented clinical results from a multi-institutional study which evaluated the efficacy of Avantis Medical Systems’ Third Eye Retroscope, a new device that improves the ability of physicians to visualise abnormalities in the colon.
The study showed that the Third Eye Retroscope, when used in combination with a standard colonoscope, detects a significantly higher number of adenomas and other polyps than the colonoscope alone. The Third Eye Retroscope has been cleared for use in the USA by the Food and Drug Administration (FDA).

'It is quite an ingenious device,' said Dr Waye. 'The technology behind it is amazing.'

Colorectal cancer is the second greatest cause of cancer death in the USA. However, most cancers of the lower gastrointestinal (GI) tract can be completely cured if they are detected early. Even more cases can be completely prevented if pre-cancerous polyps can be removed before they become malignant.

Principal investigator Dr Waye, of Mount Sinai Hospital in New York, presented the multi-centre study results. The study has evaluated 214 patients to date at eight sites across the USA. During the study, patients were examined using a Third Eye Retroscope in combination with a standard colonoscope.

'Colonoscopy is currently considered the best method for colorectal cancer screening. However, it is well-established from previous research that lesions may be missed, especially on the proximal aspect of haustral folds and flexures or behind the ileocecal valve,' said Dr Waye.

Used during colonoscopy, the Third Eye Retroscope is an auxiliary imaging device that provides retrograde illumination and visualization of the colon for diagnostic purposes. Developed by Avantis Medical Systems of Sunnyvale, California, USA, the innovative new endoscopic device is passed through the instrument channel of a standard colonoscope until it extends beyond the tip of the colonoscope. As it emerges, the device automatically turns around 180 degrees to provide a continuous retrograde view while the colonoscope is being withdrawn.

Colonoscopy is widely regarded as the ‘gold standard’ for detection of abnormalities in the colon. However, previous research has revealed that 12 to 24 percent of polyps and a significant number of cancers can be missed during colonoscopy, especially if they lie behind folds in the colon wall. Refs 1, 2, 3. This new device is designed to solve this problem by allowing the physician to view the opposite side of those folds during the procedure.

The study (which is still active) has found that, in combination with a standard colonoscope, the Third Eye Retroscope detected 13.3 percent additional polyps, and 12.4 percent additional adenomas, compared with the colonoscope alone. Polyps detected with the Third Eye were comparable in size to those seen with the colonoscope.

'Our investigators are finding that the Third Eye Retroscope is a promising new technology for improving visualisation during colonoscopy,' continued Dr Waye. 'During the study, the Third Eye revealed areas that are often hidden from the forward-viewing colonoscope, and it allowed a significant increase in detection of adenomas and other polyps.'

In the 214 patients studied to date, 203 polyps were identified with the standard colonoscope. With the Third Eye Retroscope, an additional 27 polyps were detected, an increase of 13.3 percent. With the standard colonoscope, 105 adenomas were found; and with the Third Eye Retroscope, an additional 13 adenomas were detected, an increase of 12.4 percent. Mean size for polyps found by the colonoscope alone was 0.49cm, and mean size for polyps found by the Third Eye Retroscope was virtually identical, at 0.47 m.

In 21 patients (9.8 percent), at least one additional polyp was found with the use of the Third Eye Retroscope, and in seven patients (3.3 percent), the polyp detected with the Third Eye Retroscope was the only one found.

Dr Waye is clinical professor of medicine and chief of the GI Endoscopy unit at the Mount Sinai Medical Center in New York City, USA.

Known for introducing the concept of colonoscopy without fluoroscopy by defining endoscopic landmarks, Dr Waye has authored seven books, innumerable abstracts, and has published almost two hundred scientific papers in peer- reviewed journals.

He is president-elect and has been treasurer of OMED, the international organization for digestive endoscopy. In 1980, he was president of the ASGE and in 1982 became president of the American College of Gastroenterology (ACG). He has also received the highest honors awarded by these organizations: the Schindler Award (from the ASGE) and the Founder's Award (from the ACG).

He is organizing the International Congress of Endoscopy, to be held in Los Angeles, Calif. in 2011.

Ref 1- Pickhardt, P J; Nugent, P A; Mysliwiec, P A; Choi, J R; Schindler, W R Location of adenomas missed by optical colonoscopy. Annals of Internal Medicine 141(5):352-360, 2004.

Ref 2- Pabby, A; Schoen, R E; Weissfeld, J L; Burt, R; Kikendall, J W; Lance, P; Shike, M; Lanza, E; Schatzkin, A. Analysis of colorectal cancer occurrence during surveillance colonoscopy in the dietary Polyp Prevention Trial. Gastrointestinal Endoscopy 61(3):385-391, 2005.

Ref 3- Rex, D K; Cutler, C S; Lemmel, G T; Rahmani, E Y; Clark, D W; Helper, D J; Lehman, G A; Mark, D G. Colonoscopic miss rates of adenomas determined by back-to-back colonoscopies. Gastroenterology 112(1):24-28, 1997.

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