Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate.

NCT05220345 | Completed

• 1 other identifier: NL80004.091.21
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is the gold standard for colorectal screening. The diagnostic accuracy of colonoscopy highly depends on the quality of inspection of the colon during the procedure. To increase detection new polyp detection systems based on artificial intelligence (AI) have been developed. However, these systems still depend on the ability of the endoscopist to adequately visualize the complete colonic mucosa, especially to detect smaller and more subtle lesions, or lesions hidden behind folds in the colon. With this study we want to combine a device to flatten the folds in the colon combined with an artificial intelligence system to further improve the detection rate of lesions during colonoscopy.

Conditions

Colorectal Polyp; Colonoscopy; Artificial Intelligence; Adenoma

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR)

  Calculated as the number of patients in whom at least one adenoma is detected during the colonoscopy procedure, divided by the total number of patients that underwent the colonoscopy procedure.

  30 days after procedure

Secondary Outcomes (19)

• Advanced adenoma detection rate (AADR).

  30 days after procedure

• Polyp Detection Rate

  30 days after procedure

• Sessile detection Rate

  30 days after procedure

• Indication specific ADR,

  30 days after procedure

• Mean number of adenomas detected per patient

  30 days after procedure

Study Arms (1)

colonoscopy with a combined BFT and CADe assisted approach

OTHER

This multicenter single-arm colonoscopy trial will compare colonoscopy assisted by both balloon-BFT visualizing and CADe to CADe-only assisted colonoscopy in diagnostic, screening (non-iFOBT based)), or surveillance colonoscopy. The latter group will be selected from the interventional arm from the Discovery II trial, using corresponding participating centers. All subjects in this trial will undergo the same treatment, i.e., combined balloon and CADe-assisted colonoscopy.

Device: colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe)

Interventions

colonoscopy assisted by both balloon-Behind The Folds visualizing and Computer assisted detection (CADe) DEVICE

All participants will be subjected to a colonoscopy procedure, assisted by both G-eye balloon and the Discovery CADe system. Standard of care regarding the colonoscopy procedure will be applied to all study subjects. Any lesions detected during the procedure will be removed directly

colonoscopy with a combined BFT and CADe assisted approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years)
• Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy.

You may not qualify if:

• Inflammatory bowel disease (IBD)
• Known polyp or tumor upon referral
• Therapeutic procedure (e.g., endoscopic mucosal resection)
• Prior surgical resection of any portion of the colon
• American Society of Anesthesiologists score of ≥3
• Inadequately corrected anticoagulation disorder or anticoagulation medication use
• inability to provide informed consent.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• PENTAX Europe GmbH: collaborator

Study Sites (1)

Radboud university medical center Nijmegen

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Peter D Siersema, Prof

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: International multicenter prospective interventional cohort, compared with a cohort from the Discovery II study (NL73127.091.20, trial code NL9135).

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 2, 2022
• Study Start: May 12, 2022
• Primary Completion: August 26, 2024
• Study Completion: September 26, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)