Colonoscopy Clinical Trial
Official title:
Effect of Two Colonoscopy AI Systems for Colon Polyp Detection According to the False Positive Rates of the Systems: A Single-center Prospective Study
Verified date | March 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 3046 |
Est. completion date | December 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Healthcare System Gangnam Center, Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Seoul National University |
Korea, Republic of,
Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma detection rate | proportion of colonoscopies with at least one adenoma detected overall and as detected by the physician. | 12 months | |
Primary | Sessile serrated lesion detection rate | proportion of colonoscopies with at least one sessile serrated lesion detected overall and as detected by the physician. | 12 months | |
Secondary | polyp detection rate | proportion of colonoscopies with at least one polyp detected overall and as detected by the physician. | 12 months |
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