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NCT05740137
Adenoma Detection Rate in Artificial Intelligence-assisted Colonoscopy
Conditions: Colorectal Cancer, Colorectal Adenoma, Colorectal Neoplasms
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 800
Sponsor: Ismail Gögenur
Location: Denmark
Summary
The goal of this cluster randomized multicenter controlled clinical trial (RCT) is to investigate whether a combined real time computer-aided polyp detection (CADe) and computer-aided polyp characterization (CADx) system (GI Genius, Medtronic) can increase the adenoma detection rate (ADR) and reduce the performance variability among endoscopists.Participants will be randomized (1:1) to either receive an AI-assisted colonoscopy (AIC) or a conventional colonoscopy (CC).If there is a comparison group: Researchers will compare the AIC-group and the CC-group to see if AIC can increase the ADR significantly.
Eligibility Criteria
Inclusion Criteria:Referred for screening colonoscopy due to a positive faecal immunochemical test (FIT) or forDiagnostic colonoscopy due to symptoms/signs orPost-polypectomy surveillance colonoscopy (only patients who had all detected polyps removed in the previous colonoscopy)Exclusion Criteria:Referral for removal of previous detected polypsEmergency colonoscopyControl colonoscopy due to inflammatory bowel disease (IBD)
Source: ClinicalTrials.gov (NCT05740137). StuddyBuddy aggregates publicly available trial information.