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INCREASED ADENOMA DETECTION RATE BY G-EYE™ HIGH-DEFINITION COLONOSCOPY
PROSPECTIVE RANDOMIZED MULTICENTER STUDY OF 1000 PATIENTS
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Haim Shirin , Beni Shpak , Julia Epshtein , Peter Vilmann , Arthur Hoffman , Silvia Sanduleanu , Pier Alberto
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Testoni , Sauid Ishaq , Nageshwar Reddy , Seth A. Gross , Peter D. Siersema , Helmut Neumann , Martin
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Goetz , Dov Abramowich , Menachem Moshkowitz , Meir Mizrahi , Jakob Hendel , Johannes W. Rey ,
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Rogier de Ridder , Edi Viale , Hrushikesh Chaudhari , Mark B. Pochapin , Michael Yair , Mati Shnell , Shaul
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Yaari , Trine Stigaard , Roman Simantov , Nathan Gluck , Eran Israeli , Stine Sloth , Shay Matalon ,
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Alexander Vilkin , Ariel Benson , Amit Maliar , Amir Waizbard , Tiberiu Hershcovici , Eyal Shachar , Shmuel
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Rochberger , Eduard Tsvang , Michal Braverman , Harold Jacob , Yuri Brachman , John Gasdal
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Karstensen , Daniel Teubner , Roel Bogie , Ralf Kiesslich
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Institute of Gastroenterolgy, Liver Diseases and Nutrition, Assaf Harofeh Medical Center, Israel
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Gastroenterology Institute, Laniado Hospital, Israel
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Institute of Gastroenterology and Liver Diseases, Hadassah Medical Center, Israel
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Department of Gastroenterology, Copenhagen University Hospital Herlev, Denmark
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Internal Medicine, HSK Dr. Horst-Schmidt-Kliniken, Germany
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Dept. of Gastroenterology and Hepatology, UMC Maastricht, Netherlands
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Gastroenterology and Digestive Endoscopy, San Raffaele Hospital, Italy
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Gastroenterology Department, Russell's Hall, UK
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Gastroenterology & Therapeutic Endoscopy, Asian institute of gastroenterology, India
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Division of Gastroenterology, NYU Langone Medical Center, USA
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Dept. of Gastroenterology and Hepatology, UMC Radboud, Netherlands
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Internal Medicine and Gastroenterology, Universitätsmedizin Johannes Gutenberg University Mainz,
Germany
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Internal Medicine, Universitätsklinikum Tübingen, Germany
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Gastroenterology division, Advanced endoscopy center, Beth Israel Deaconess Medical Center, Harvard
Medical School, USA
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Background: While colonoscopy is known to be the "gold standard" for colorectal cancer screening, a significant
number of adenomas are still missed during Standard Colonoscopy (SC), e.g., due to polyps hidden behind colon
folds and flexures. The G-EYE™ endoscope (Smart Medical Systems Ltd., Ra’anana, Israel) comprises a forwardviewing endoscope with a permanently integrated balloon at the distal end. Upon withdrawal of the colonoscope, the
G-EYE™ balloon is partially inflated, resulting in the flattening of haustral folds, centralization of the endoscopic optics,
and reduction in bowel slippage. This provides enhanced visualization of the colon and thus increases detection of
adenomas. Our 1000 patients study compares the adenoma detection rate (ADR) of G-EYE™ colonoscopy with that
of SC. Aims and Methods: In this randomized, prospective, multicenter study, patients (age 50) referred to
colonoscopy for screening, surveillance, following positive FOBT, or due to change in bowel habits were randomized
to G-EYE™ colonoscopy or SC. Results: 1000 patients were enrolled in the study, of which 498 underwent SC and
502 underwent G-EYE™ colonoscopy. Baseline parameters, indication for colonoscopy, and procedural times were
similar in both groups. Results are presented in Table 1. Compared to SC, G-EYE™ colonoscopy improved ADR by
29.8%. The G-EYE™ endoscope increased not only the detection of diminutive and small adenomas, but advanced
and large-sized adenomas as well. Moreover, G-EYE™ colonoscopy increased the detection of flat and sessile
serrated adenomas by 158.3% and 228.6%, respectively.
Conclusions: Our study shows that G-EYE™ colonoscopy demonstrates a higher ADR, increased detection of
advanced adenomas, and a higher rate of adenoma per patient when compared to SC. Special interest should be paid
to the increased number of sessile serrated adenomas, as these lesions are strongly associated with CRC. Improved
detection by the G-EYE™ endoscope can impact the quality of CRC screening, reduce miss rates, and consequently
reduce the incidents of interval cancers.