Impact on Polyp Detection of a Computer Aided Detection System (CADEYE) Combined With a Balloon Mucosal Exposure Device (G-EYE 760R) in Individuals Participating in a Organized Colorectal Cancer Screening Program
Trial ID: NCT05829447
Status: COMPLETED
Study type: INTERVENTIONAL
Phase: NA
Start date: 2023-05-01
Completion date: 2023-12-01
Sponsor: Valduce Hospital
Conditions: Polyp of Colon
Interventions: G-EYE 760 R endoscope
Locations: Gastroenterology Unit, Valduce Hospital
Countries: Italy
Enrollment: 686
Age range: 50 Years - 74 Years
Sex: ALL

Summary:
The present trial is aimed at evaluating whether in individuals scheduled for colonoscopy in the framework of a structured FIT (Fecal Immunochemical stool test)-based colorectal cancer screening program, the combination of an AI (artificial intelligence) system (CADEYE) with a mucosal exposure device (G-EYE 760R endoscope) increases the identification of subjects at high risk to develop colorectal cancer (according to recent ESGE-European Society of Gastrointestinal Endoscopy guidelines subjects are labelled as "high-risk" if harboring at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia) when compared to colonoscopy performed with the support of AI only.

Individuals fulfilling inclusion criteria are randomized (1:1) to two different arms (Control arm and Interventional arm, see below). Randomization is based on a computer-generated randomized block sequence, stratified according to age (50-61 vs. 62-74) and gender (male vs. female); size of the blocks (10 individuals) is not communicated to the investigator. Allocation is concealed and kept in a sealed envelope, which is opened just before starting colonoscopy.

Individuals randomized in the Intervention arm receive colonoscopy examination with G-EYE 760R colonoscopes; once the cecum is reached the balloon is inflated, and the endoscope is withdrawn with the inflated balloon; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination.

Individuals randomized in the Control arm (CADEYE only) receive colonoscopy with G-EYE 760R colonoscope but the balloon remains deflated for the entire procedure; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination.

The main outcome measure is the rate of "high risk" individuals across the two study arms.

Eligibility criteria:
Inclusion Criteria:

* Consecutive adult (50-74 yrs.) outpatients undergoing colonoscopy in the framework of the FIT-based screening program.

Exclusion Criteria:

* Individuals with CRC (Colorectal Cancer) history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
* Individuals with inadequate bowel preparation (defined as Boston Bowel Preparation score \<2 in at least one colonic segment)
* Individuals in which cecal intubation was not achieved or scheduled for partial examinations
* Individuals with gastrointestinal symptoms
* Individuals in whom polyps could not be resected due to ongoing anticoagulation preventing resection and pathological assessment

Outcomes:
Rate of "high risk" patients