Prospective, Randomized, Multicenter, Tandem Study Evaluating the Safety and Effectiveness of the CB-17-08 Augmented Endoscopy System for the Detection of Mucosal Colorectal Polyps in Adult Patients Undergoing Screening or Surveillance Colonoscopy for CRC.

Study procedure:

Patients will be randomized (1:1) to one of the arms by an IWRS system. Randomization will be stratified by study endoscopist, to balance the number of patients randomized to either of the study groups (1:1) within the same endoscopist, by age (from to 45 to <65 years old; ≥65 years old) and by reason for colonoscopy (screening, surveillance <3 years from previous colonoscopy, surveillance 3-10 years from previous colonoscopy). Each endoscopist shall not enrol more than 90 patients.

The following study visits are foreseen for each patient:

Screening Visit A screening visit is performed at the investigational site. During this visit out-patients scheduled for colonoscopy will be informed about the aims, procedures, benefits and possible risks of the study prior to signing the informed consent form for inclusion in the study. Their medical history will be recorded as well as eventual clinical or laboratory examinations according to the local standard of care preparation for a colonoscopy, ) and the date for the colonoscopy procedure to be performed at the investigational site will be scheduled.

Tandem Colonoscopy Visit Each eligible patient returns to the clinic to undergo a same-day, back-to-back tandem colonoscopy examination performed by the same experienced endoscopist. The randomized allocation will determine whether patients will undergo standard high-definition white light colonoscopy with CB-17-08 immediately followed by standard high definition white light colonoscopy or standard high definition white light colonoscopy followed by standard high definition white light colonoscopy with CB-17-08.