A Multicenter Single-Arm Prospective Performance Evaluation Study to Assess the Performance of an AI Instrument to Support Qualitative Diagnosis of Colorectal Polyps (MASTERPIECE study)

未提供0 个研究点目标入组 170 人开始时间: 2022年5月10日最近更新: 2023年12月1日

试验速览

暂无简介。

•1.Patients between 20 and 85 years old at the time of registration who undergo colonoscopy
•2.Patients who undergo colonoscopy (patients who meet any of the following conditions)
•Positive fecal occult blood
•Patients who need to undergo surveillance colonoscopy after polypectomy for colorectal polyp (including mucosal resection and submucosal dissection for early stage cancer)
•Patients who have gastrointestinal symptoms such as abdominal pain, diarrhea or constipation
•Patients who need to undergo screening colonoscopy for colorectal cancer
•Patients who are recommended to undergo colonoscopy by their physician
•3.Patients who can understand the content forms, those who can make a decision by themselves and those who can give written consent

•1.Patients with inflammatory bowel disease
•2.Patients with familial adenomatous polyposis
•3.Patients with a history of colorectal resection except appendicectomy
•4.Patients with colorectal stenosis
•5.Pregnant patients
•6.Patients with abnormal blood coagulation function
•7.Patients who cannot be managed with anticoagulant and/or antiplatelet agents according to the guidelines published by Japan Gastroenterological Endoscopy Society
•8.Patients with severe organ failure
•9.Patients who are not suitable for enrollment in the present study judged by their physician

Accuracy of endoscopic diagnosis with AI

Sensitivity and specificity of endoscopic diagnosis with AI
Accuracy, sensitivity and specificity of endoscopic diagnosis made by endoscopists
Differences of accuracy, sensitivity and specificity of endoscopic diagnosis between trainees and experts of colonoscopy
Differences of accuracy, sensitivity and specificity of endoscopic diagnosis by characteristics of lesions between endoscopists and AI
Differences of endoscopists confidence level on endoscopic diagnosis between diagnosing with AI and without AI
Rates of adverse events

发起方

未提供