• Polyp detection rate [PDR] [ Time Frame: Day 1 ]
  Polyp detection rate [PDR], defined as proportion of patients with at least one histologically confirmed clinically relevant polyp detected in the first colonoscopy.
• Adenoma miss rate [AMR] [ Time Frame: Day 1 ]
  Adenoma miss rate [AMR], defined as the number of histologically confirmed adenomas and carcinomas detected during the second colonoscopy divided by the total number of adenomas and carcinomas detected during the first and second colonoscopy.
• Adenoma detection rate [ADR] [ Time Frame: Day 1 ]
  Adenoma detection rate [ADR], defined as the proportion of patients with at least one histologically confirmed adenoma or carcinoma detected in the first colonoscopy.
• False Positive Rate [FPR] [ Time Frame: Day 1 ]
  False Positive Rate [FPR], defined as the proportion of colorectal lesions resected or biopsies and subsequently not histologically confirmed to be clinically relevant colorectal polyps. All the biopsied or ablated specimens which will be histologically confirmed not to be polyps (e.g. normal mucosa, inflammatory tissue, stools or debris, etc.) will be classified as False Positives.
• Endoscopist satisfaction grade [ Time Frame: Day 1 ]
  Endoscopist satisfaction grade, calculated through a specific questionnaire to evaluate the degree of satisfaction/noise when using CB-17-08 during endoscopy in real time.
• Adverse Events [ Time Frame: Day 1 ]
  Adverse Events number and severity.

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.

Bowel preparation will be done according to the usual standard of care protocols of the individual sites. The quality of bowel preparation will be assessed during colonoscopy using the Boston Bowel Preparation Scale (BBPS). Sedation according to the sites best experience and standard procedures will be delivered to the patient by the endoscopist or an anaesthesiologist.

Subjects' vital signs (blood pressure [BP], hearth rate [HR] and oxygen saturation [SpO2]) will be measured and monitored prior to, during and at the end of the tandem colonoscopy procedure.

The endoscopist will be instructed to adhere to their usual withdrawal technique and to spend a minimum of 6 minutes withdrawing and examining the colonic mucosa. Time to reach the caecum and time to withdrawal from caecum to exit will be recorded for each colonoscopy. Clean withdrawal time, i.e. withdrawal time excluding the time spent for procedures or washings (if any), will be recorded. At least 6 minutes of clean withdrawal time will be required for all colonoscopies, in accordance to the current ASGE guideline. Withdrawal time, total procedure time, and time for pauses to allow polypectomies and biopsies to be performed will be recorded. Repeated examination of any of the colon segments (e.g. right colon) in normal modality or in retroflexion is not permitted.

Each colorectal polyp detected during the first procedure, as well as each polyp detected during the second procedure, will be immediately removed or biopsied and will be sent to the central histology laboratory for characterization. When a mucosal polyp is detected, its estimated size and morphological appearance according to Paris classification will be reported by the endoscopist on the CRF, as well as the anatomical location inside the colonic districts. On the basis of histological examination, polyps will be categorized according to revised Vienna classification and serrated lesion classification.

• Experimental: With CB-17-08 CADe
  Intervention: Device: CB-17-08 CADe
• No Intervention: Without CB-17-08 CADe

Inclusion Criteria:

• Male and female patients age: ≥45 years;
• Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy for CRC;
• Willingness to undergo tandem colonoscopies with and without the use of CB-17-08 on the same day and in the same procedural setting;
• Ability to provide written, informed consent and understand the responsibilities of trial participation;

Exclusion Criteria:

• The subject is pregnant or is planning a pregnancy during the study period;
• History of inflammatory bowel disease (IBD);
• History of colon resection;
• History of Familial adenomatous polyposis (FAP) syndrome or of Serrated Polyposis Syndrome (SPS);
• History of overt lower GI bleeding;
• History of colonic stricture;
• History of radiation therapy to the abdomen or pelvis;
• Patients with contraindications to colonoscopy such as presence of acute diverticulitis or toxic megacolon;
• Subjects with particular symptoms (e.g diarrhea) who, per clinical practice, have to undergo random biopsies in the colon.

Fecal Occult Blood Test (FOBT) or Fecal Immunochemical Test (FIT) positive patients will not be excluded from the study.