SAN DIEGO — The G-Eye Colonoscope Platform, which uses a balloon to smooth intestinal folds, demonstrated substantial improvement over standard colonoscopy, a speaker said here.
The device from Smart Medical Systems fits a permanently integrated reusable balloon over any colonoscope, Seth A. Gross, MD, director of endoscopy, Tisch Hospital, NYU Langone Medical Center, said during the American College of Gastroenterology Annual Scientific Meeting. It does not require any single-use accessory or any pre-procedure preparation.
The balloon is deflated while the endoscope is inserted, until the cecum is reached. The balloon is then inflated to a predetermined, user-selected pressure level. As the scope is pulled, back, the balloon straightens colon folds and smoothes the topography to allow for a more complete view, according to Gross.
A prospective multicenter, randomized, tandem study of the device divided 106 patients into two groups. One group (n=54) had standard colonoscopy followed by G-Eye colonoscopy. The other group (n=52) had G-Eye first, followed by standard colonoscopy.
In the group undergoing standard colonoscopy first, 30 polyps and 21 adenomas were detected. When the patients underwent a second colonoscopy with the G-Eye, 30 additional polyps and 17 additional adenomas were discovered, Gross said.
In the second group, the first colonoscopy with the G-Eye found 51 polyps and 37 adenomas. The second pass with a standard colonoscope found three additional polyps and three additional adenomas for a G-Eye miss rate of 5.6% for polyps and 7.5% for adenomas, he said.
In addition, the false negative and miss rate were both zero for G-Eye, while they were 5.8% and 17.6%, respectively, for standard colonoscopy, Gross said.
The G-Eye Colonoscope platform has been CE mark approved in Europe and is pending approval by the FDA, Gross said. A larger, standardized, comparative study is being initiated.
Disclosure: Gross reports no relevant financial disclosures.
For more information:
Gross SA. #21: A Novel Balloon-Colonoscope for Increased Polyp/Adenoma Detection Rate: Results of a Randomized Tandem Study. Presented at: the 2013 American College of Gastroenterology Annual Scientific Meeting; Oct. 11-16, San Diego.