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Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals

NCT05829447 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 686

Last updated 2024-03-26

No results posted yet for this study

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examination with G-EYE 760R colonoscopes; once the cecum is reached the balloon is inflated, and the endoscope is withdrawn with the inflated balloon; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all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.

Conditions

  • Polyp of Colon

Interventions

DEVICE

G-EYE 760 R endoscope

The G-EYE 760 endoscope consists of a standard last-generation colonoscope with a permanently integrated balloon, placed at the bending section of the endoscope, which can be gradually insufflated on-demand by the endoscopist through a pedal control. During the endoscope withdrawal the balloon flattens haustral folds, centralizes the colonoscope's optics and reduces bowel slippage, thus facilitating mucous inspection and polyp detection.

Sponsors & Collaborators

  • Valduce Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829447 on ClinicalTrials.gov