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

NCT05220345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-08-15

No results posted yet for this study

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

Interventions

DEVICE

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

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

Sponsors & Collaborators

  • PENTAX Europe GmbH

    collaborator INDUSTRY

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Peter D Siersema, Prof · Radboud University Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-12
Primary Completion
2024-08-26
Completion
2024-09-26

Countries

  • Netherlands

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 NCT05220345 on ClinicalTrials.gov