Clinical trial · Interventional
Combining Artificial Intelligence With Balloon Mucosal Exposure Device for Polyp Detection in Screening Individuals
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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examination with G-EYE 760R colonoscopes; once the cecum is reached the balloon is inflated, and the endoscope is withdrawn with the inflated balloon; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G-EYE 760 R endoscope | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- GI-EYE endoscope with inflated ballon (Interventional arm)
- description
- all individuals 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.
- interventionNames
- Device: G-EYE 760 R endoscope
- type
- NO_INTERVENTION
- label
- G-EYE endoscope with deflated balloon (Control arm)
- description
- all subjects 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
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available