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The validation study of detectability and diagnostic accuracy of AI-aided endoscopic diagnosis system for colonoscopy

The validation study of detectability and diagnostic accuracy of AI-aided endoscopic diagnosis system for colonoscopy; multicentric study - CAD-COLON study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032190061
Enrollment
358
Registered
2019-07-24
Start date
2019-08-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal polyps Colorectal adenoma/cancer/polyp

Interventions

Detection and diagnosis support for colorectal lesions to doctors by AAE system 1.Standard colonoscopy-first-group: Standard colonoscopy is performed first, followed by colonoscopy under the support
Artificial Intelligence/Detection and diagnosis support

Sponsors

Tamai Naoto
Lead Sponsor
Sumiyama Kazuki
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In patients scheduled for colonoscopy / treatment, patients who meet the following criteria. 1.40-80 years old 2.Patients who gave written informed consent based on their own intention after receiving sufficient explanation about this study 3.Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found 4.The examination purpose is for screening of colon cancer or surveillance after endoscopic treatment of colorectal lesions

Exclusion criteria

Exclusion criteria: 1.Patients with known inflammatory bowel disease and colonic stenosis 2.Patients with known familial adenomatous polyposis syndrome 3.Patients with known colorectal cancer/polyp 4.Patients who have had colon surgery in the past (except for appendectomy and surgery on the anus) 5.Patients with high risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet agent. 6.Patients with severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D) 7.Pregnant patient 8.Patients who are judged as ineligible for registration by attending doctors

Design outcomes

Primary

MeasureTime frame
Adenoma miss rate

Secondary

MeasureTime frame
Adenoma miss rate per patient, Adenoma detection rate, Polyp miss rate, Polyp miss rate per patient, Polyp detection rate, Mean number of adenomas per procedure

Contacts

Public ContactShunsuke Kamba

The Jikei University School of Medicine

kanba@jikei.ac.jp+81-3-3433-1111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026