Computer Aided Detection of Polyps in Colonoscopy

Iterative Scopes, Inc1,472 enrolled

Overview

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

DOUBLE

Enrollment

1,472

Conditions

Colorectal Polyp

Interventions

Computer Aided Detection deviceDEVICE

The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria Participants will be eligible for this study if they are: * Undergoing colonoscopy with screening, surveillance, or diagnostic indications. * Undergoing a procedure by a participating endoscopist. * Have given informed consent. Exclusion Criteria Participants will not be eligible for this study if they: * Have a history of inflammatory bowel disease. * Have a history of familial adenomatous polyposis. * Are under the age of 40. * Have had a colonoscopy within the previous three (3) years. * Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test. * Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator). * Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.

Locations (5)

Massachusetts General Hospital

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Mount Auburn Hospital

Cambridge, Massachusetts, United States

MNGI Digestive Health

Plymouth, Minnesota, United States