Status:
COMPLETED
Synergistic Effect of G-Eye Balloon for Behind the Folds Visualization With CADe (Discovery System) on Adenoma Detection Rate.
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
PENTAX Europe GmbH
Conditions:
Colorectal Polyp
Colonoscopy
Eligibility:
All Genders
18+ years
Phase:
NA
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 n...
Detailed Description
Rationale: Colonoscopy is the gold standard for CRC screening. The adenoma detection rate (ADR) is the most important quality parameter for colonoscopy, because of its inverse association with the ris...
Eligibility Criteria
Inclusion
- Adult patients (\>18 years)
- Referred and scheduled for diagnostic, screening (non-iFOBT based), or surveillance colonoscopy.
Exclusion
- 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.
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2024
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT05220345
Start Date
May 12 2022
End Date
September 26 2024
Last Update
August 15 2025
Active Locations (1)
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1
Radboud university medical center Nijmegen
Nijmegen, Gelderland, Netherlands, 6500 HB