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

JRCT ID: jRCTs032190061

Registered date:24/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Colorectal polyps
• Date of first enrollment: 14/08/2019
• Target sample size: 358
• Study type: Interventional

Intervention(s)

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 of the AAE system
2.AAE-first-group: Colonoscopy under the support of the AAE system is performed first, followed by normal colonoscopy
All colorectal polyps detected in any group are removed

Outcome(s)

• Primary Outcome: Adenoma miss rate
• Secondary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tamai Naoto
• Secondary Sponsor: Sumiyama Kazuki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development