An interventional study of Colonoscopy with CADe system in Colorectal Polyps, sponsored by Gian Eugenio Tontini. Completed at 1 site in Italy. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Gian Eugenio Tontini · Not applicable, Interventional, and Diagnostic
High-definition (HD) colonoscopy is the gold standard for early diagnosis and treatment of lower gastrointestinal neoplasms, with the adenoma detection rate (ADR) serving as a key quality indicator due to its inverse correlation with colorectal cancer incidence. ADR is influenced by operator expertise, fatigue, and human error, which may be mitigated by advanced imaging technologies such as computer-aided detection (CADe). CADe systems provide real-time visual and auditory alerts for suspected polyps and have been shown to increase ADR, though their effectiveness under different operator conditions (high- vs. low-volume, fatigue-related performance, impact on polyp detection rate [PDR] and withdrawal time) remains unclear. This multicenter, prospective, national, open-label randomized trial (6 Italian centers) will compare HD-Iscan colonoscopy with and without CADe assistance (1:1 allocation), with primary endpoint ADR and secondary endpoints including PDR, withdrawal time, and performance stratified by operator fatigue. Eligible patients (aged 40-80, undergoing screening, surveillance, or diagnostic colonoscopy) will be recruited consecutively, with exclusions for prior colonic resection, recent diverticulitis, inflammatory bowel disease, familial polyposis, inadequate bowel preparation, complete colonoscopy within 5 years, inability to consent, or unsafe ongoing antithrombotic therapy. Colonoscopies will follow ESGE guidelines with standard split-dose PEG preparation; all polyps will be resected and documented. Operator allocation to high- (≥200 colonoscopies/year) or low-volume (\<200/year) groups will follow routine clinical scheduling, with stratified analyses performed. The trial involves no investigational drugs or additional invasive procedures, and no adverse events are anticipated beyond those inherent to colonoscopy.
This is the only study on the registry with Gian Eugenio Tontini as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
colonoscopy with CADe system
Device: Colonoscopy with CADe system
colonoscopy without CADe system
Patients in the CADe+ arm underwent colonoscopy with CADe DISCOVERY™ (PENTAX Medical, Tokyo, Japan), an AI-driven tool highlighting suspected lesions in real-time, through a light-blue box. The final lesion characterization remained the endoscopist's responsibility.
Adenoma Detection Rate
Adenoma detection rate (ADR) is the percentage of patients with at least one histologically proven adenoma or carcinoma
Time frame: 2 weeks
Plan to share: Yes — Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices).
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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