An interventional study of Assist by artificial intelligence system for colon polyp detection in Adenoma, Colonoscopy and Sessile Serrated Adenoma, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 45 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-27.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic
Computer-aided detection (CADe) systems have been actively researched for polyp detection in colonoscopy. The investigators aim to identify the effect of two CADe systems according to the system performance on false positive rate
Artificial intelligence technology based on deep learning is being applied in various medical fields, and research is being actively conducted to develop computer-aided detection (CADe) systems for colonoscopies to overcome the limitation of the variance of human skills. These well-trained CADe systems demonstrated high performance for neoplastic polyp detection and reported a 44% increase in adenoma detection rate (ADR) for endoscopists. However, the level of performance in the CADe system is not clear for expert endoscopists to be useful for ADR increase.
Furthermore, false positives(FPs) of the CADe system may negatively influence ADR during a screening colonoscopy. Accordingly, the investigators sought to identify the effect of the colonoscopy CADe system according to FP performance in endoscopists with various levels. The investigators hypothesized that the CADe system with low FPs would be useful to prevent the decrease in ADR in case of a high endoscopy workload according to the performance of CADe systems.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 3,046 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
patient for screening or surveillance colonoscopy patients agreed with participating in the study
Exclusion Criteria:
patients who do not agree with participating in the study patients with a history of colon resection patients with a history of inflammatory bowel resection patients with poor bowel preparation
Endoscopists perform colonoscopy with CADe system
Device: Assist by artificial intelligence system for colon polyp detection
Endoscopists perform colonoscopy without CADe system
Assist by artificial intelligence system for colon polyp detection
Adenoma detection rate
proportion of colonoscopies with at least one adenoma detected overall and as detected by the physician.
Time frame: 12 months
Sessile serrated lesion detection rate
proportion of colonoscopies with at least one sessile serrated lesion detected overall and as detected by the physician.
Time frame: 12 months
polyp detection rate
proportion of colonoscopies with at least one polyp detected overall and as detected by the physician.
Time frame: 12 months
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital