Clinical vAliDation of ARTificial Intelligence in POlyp Detection

This is an investigator-initiated non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided detection (CADe) tool for colorectal polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Consecutive patients referred for a screening, surveillance or diagnostic colonoscopy will be included.

Patients will undergo a standard colonoscopy performed by a trained endoscopist. A second observer, who is not a trained endoscopist, will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative or (3) false positive. In case of a detection of the AI-system that was not seen by the endoscopist or unclear to the second observer, the second observer will ask to re-evaluate the indicated region to determine whether after second look the endoscopist has to take extra action. The entire procedure will be recorded.

There are no additional risks specific to the use of the AI tool to be taken into account. General risk of colonoscopy (i.e.: perforation, bleeding or post-polypectomy syndrome) could occur with the same frequency as that of a colonoscopy without the use of this AI tool.

All patients will receive a standard of care protocol during their colonoscopy. The AI system can only have a beneficial outcome for the patient, a better polyp detection, as it has shown to be non-inferior in terms of accuracy when compared to high detecting endoscopist in our pilot trial

Inclusion criteria

• Age ≥40 years
• Referral for screening, surveillance or diagnostic colonoscopy
• Able to give informed consent by the patient or by a legal representative

Exclusion criteria

for study inclusion

• <40 years old
• Referral for a therapeutic colonoscopy
• Known Lynch syndrome or Familial Adenomatous Polyposis syndrome
• Any contraindication for colonoscopy or biopsies of the colon
• Uncontrolled coagulopathy
• Confirmed diagnosis of inflammatory bowel disease prior to the scheduled colonoscopy
• Short bowel or ileostomy
• Pregnancy

Exclusion criteria

for study analysis

• Colonic inflammation of > 30cm during colonoscopy
• Incomplete colonoscopy for any reason
• Incomplete recording or technical failure of the artificial intelligence system