Colorectal Polyp Clinical Decision Support Device Study

Evaluation of the Clinical Performance of an Investigational Real-Time Colorectal Polyp Clinical Decision Support Device (CDSD)

The study objective is to establish the efficacy of the colorectal polyp Clinical Decision Support Device (CDSD) in clinical use.

Prospective, single arm, multicenter study with participating endoscopists comprising a range of clinical experience.

Consecutive consented patients meeting the entrance criteria will undergo standard colonoscopy with the adjunctive use of CDSD. Sensitivity and specificity of CDSD-unaided and CDSD-aided predictions will be compared with the ground truth of histopathology.

Inclusion Criteria:

• ≥ 18 years of age
• Willing and able to provide informed consent
• Subjects undergoing colonoscopy

Exclusion Criteria:

• Polyposis syndromes including Familial Adenomatous Polyposis Syndrome
• Inflammatory Bowel Disease
• Hereditary Non Polyposis Colorectal Cancer
• Severe coagulopathy
• Subjects scoring less than 6 on the Boston Bowel Prep Score or scoring less than 2 in any colon segment.
• No diminutive polyps detected during colonoscopy