Clinical Research Studies

The purpose of this study is to evaluate the feasibility of using a catheter with a retractable attached 0-20mm measurement device for measuring the size of polyps detected during a screening or surveillance colonoscopy, and to compare the measurements ascertained with this device with those measurements obtained through standard, device-free optical assessment. The device is investigational which means it has not been approved by the US Food and Drug Administration (FDA). This study uses a new device for colonoscopies to better measure each polyp, which we hope will improve patient care. The device is named the Napoleon and is a retractable, expandable/collapsible “little ruler” measuring from 0mm to 20mm, which is contained within a catheter. Like a standard colonoscopy snare (a small metal loop), the catheter with the measuring device is inserted through the colonoscope. The endoscopist extends the catheter with measuring device through the colonoscope, places it next to the polyp, measures the polyp, and retracts the catheter with measuring device back into the colonoscope. The device is single use and sterile. Colorectal cancer is the second-leading cause of cancer death in the United States. Colonoscopies are recommended to begin at age 50 for most people. This allows for the detection and removal of colorectal polyps, some of which can progress into cancer. Polyp size is the main basis for determination of timing of the interval for surveillance colonoscopy after the polyp is removed and determined to be an adenoma or sessile serrated polyp.