CB-17-08 Augmented Endoscopy System for Mucosal Lesion Detection During Colonoscopy for Colon Rectal Cancer.

The aim of this study is to assess the performance of the CB-17-08 to help endoscopists find potential mucosal polyps during the colonoscopy procedure, without significant noise disturbing the endoscopist attention, nor negative interference with the lesions detection than with the standard colonoscopy alone: the study will investigate whether the use of the device provides an increase in the number of adenomas per colonoscopy as compared to standard colonoscopy. The study will also evaluate the safety of the CB-17-08, assessing if the use of the system increases the total number of excisions without a commensurate number of adenomas as compared to standard colonoscopy.

Sex

All

Minimum age

45 Years

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.

• DERIVEDWallace MB, Sharma P, Bhandari P, East J, Antonelli G, Lorenzetti R, Vieth M, Speranza I, Spadaccini M, Desai M, Lukens FJ, Babameto G, Batista D, Singh D, Palmer W, Ramirez F, Palmer R, Lunsford T, Ruff K, Bird-Liebermann E, Ciofoaia V, Arndtz S, Cangemi D, Puddick K, Derfus G, Johal AS, Barawi M, Longo L, Moro L, Repici A, Hassan C. Impact of Artificial Intelligence on Miss Rate of Colorectal Neoplasia. Gastroenterology. 2022 Jul;163(1):295-304.e5. doi: 10.1053/j.gastro.2022.03.007. Epub 2022 Mar 15. PMID 35304117