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

NCT05829447 | Completed

• 1 other identifier: Valduce Hospital
• Study Type: interventional
• Target: 686
• Locations: 1 country
• Sites: 1

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examination with G-EYE 760R colonoscopes; once the cecum is reached the balloon is inflated, and the endoscope is withdrawn with the inflated balloon; the colonoscopy is performed with the support of the CADEYE system for polyp detection in both insertion and withdrawal phase; all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

Outcome Measures

Primary Outcomes (1)

• Rate of "high risk" patients

  Rate of individuals labelled as "high risk" to develop colon cancer according to recent ESGE guidelines (i.e. subjects harboring at least 1 adenoma ≥ 10 mm or with high grade dysplasia, or ≥ 5 adenomas, or any serrated polyp ≥ 10 mm or with dysplasia).

  through study completion, an average of 6 months

Secondary Outcomes (4)

• Adenoma detection rate

  through study completion, an average of 6 months

• Adenomas per colonoscopy

  through study completion, an average of 6 months

• Serrated lesion detection rate

  through study completion, an average of 6 months

• Right sided adenoma detection rate

  through study completion, an average of 6 months

Study Arms (2)

GI-EYE endoscope with inflated ballon (Interventional arm)

EXPERIMENTAL

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.

Device: G-EYE 760 R endoscope

G-EYE endoscope with deflated balloon (Control arm)

NO INTERVENTION

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

Interventions

G-EYE 760 R endoscope DEVICE

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.

GI-EYE endoscope with inflated ballon (Interventional arm)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Valduce Hospital: lead

Study Sites (1)

Gastroenterology Unit, Valduce Hospital

Como, 22100, Italy

Location

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Gastroenterology Unit

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: April 25, 2023
• Study Start: May 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)