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Clinical Trials/NCT05089071
NCT05089071
Completed
Not Applicable

Effect of Two Colonoscopy AI Systems for Colon Polyp Detection According to the False Positive Rates of the Systems: A Single-center Prospective Study

Seoul National University Hospital1 site in 1 country3,046 target enrollmentNovember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adenoma
Sponsor
Seoul National University Hospital
Enrollment
3046
Locations
1
Primary Endpoint
Sessile serrated lesion detection rate
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
December 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Sessile serrated lesion detection rate

Time Frame: 12 months

proportion of colonoscopies with at least one sessile serrated lesion detected overall and as detected by the physician.

Adenoma detection rate

Time Frame: 12 months

proportion of colonoscopies with at least one adenoma detected overall and as detected by the physician.

Secondary Outcomes

  • polyp detection rate(12 months)

Study Sites (1)

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