Computer Aided Detection of Polyps in the Colon

Length of Study - The duration of the study is expected to be 8-12 months. Enrollment of study patients will cease when approximately 250 patients have been enrolled.

Study Design- Design will be a multi-center, prospective, unblinded randomized control trial. Patients referred for either screening or surveillance colonoscopy will be included.

Equipment: Aside from standard of care scope used, a second computer monitor that will stand behind the standard monitor used during colonoscopy. Additionally , a computer system unit with an operating system.

Standard Clinical Procedure Typically, intravenous sedation using a combination of benzodiazepine and narcotic medications (with or without propofol under the supervision of a trained anesthesiologist) are used for colonoscopy. Continuous pulse oximetry and blood pressure monitoring is used throughout the procedure. Supplemental oxygen is used as needed. Patients are usually placed in the left lateral decubitus position and the colonoscope is introduced into the rectum. The colonoscope is advanced under direct visualization until the cecum and appendiceal orifice is reached. The colonoscope is usually retroflexed within the rectum. The colonoscopist carefully inspects each segment of colon during advancement and then again on withdrawal of the colonoscope. Any suspicious lesions encountered during insertion or withdrawal are inspected by the colonoscopist and a final determination is made by the clinician on whether or not to remove a given lesion. Any lesion that is deemed suspicious or polypoid is removed by en-bloc polypectomy, piecemeal polypectomy, or may be referred for endoscopic mucosal resection (EMR) at a later date. After the procedure, patients recover in the post-procedural recovery room. After the procedure, results are discussed with the patient. The ability of colonoscopy to detect lesions is discussed with the patient as well as the fact that a small percentage of polyps and other lesions may be missed during the test.

Study Procedure Patients will receive a colonoscopy with a gastroenterologist. During the standard clinical procedural protocol and for the study period, colonoscopists will have the benefit of a second monitor that will project the polyp detection algorithm in real-time over the video output of the colonoscopy. The algorithm will detect suspicious, polyp-like lesions within the lumen of the colon, and during the procedure a research assistant will view the second monitor at all times and record a time stamp for any potential polyps on an intra-procedural data collection sheet.