JPRN-jRCTs072220003已完成2 期
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
raoka Toshio0 个研究点目标入组 176 人开始时间: 2022年4月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
研究概览
简要总结
The full analysis set consisted of 139 subjects with 380 lesions. Endoscopists diagnosed colorectal lesions with white light, non-magnified BLI, and magnified BLI, and endoscopic resection was performed after AI diagnosis. The sensitivity, specificity, and accuracy were evaluated using the histopathology results as the gold standard; the accuracy for AI diagnosis with magnified BLI was 88.7%, which is similar to previous reports.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 85age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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