Collecting Real-world Data on Endoscopic and Histopathological Outcomes of Screening and Surveillance Colonoscopies for the Development of a CAD (Computer Aided Detection) System: A Prospective, Multicenter, Post-market Investigation

Olympus Europe SE & Co. KG2 个研究点分布在 2 个国家目标入组 600 人2024年3月12日

适应症Colonic Polyp

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Colonic Polyp
发起方: Olympus Europe SE & Co. KG
入组人数: 600
试验地点: 2
主要终点: Videos and still images of the colonoscopy
状态: 已完成
最后更新: 上个月

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

The objective of this study is to collect colonoscopy data for use in the development and testing of artificial intelligence (AI) devices for colonoscopies.

详细描述

The primary objective of this study is to collect colonoscopy data for use in the development and performance evaluation of AI devices. The data will be collected during routine colonoscopy procedures. Biopsy or resection will be performed if needed and all specimens will be sent for histopathological examination. The histopathological results will be recorded.

注册库

clinicaltrials.gov

开始日期

2024年3月12日

结束日期

2025年10月30日

最后更新

上个月

研究类型

Observational

性别

All

研究者

发起方

Olympus Europe SE & Co. KG

责任方

Sponsor

入排标准

入选标准

•Patients aged 18 years or older
•Patients who have signed a written consent form from their voluntary decision after receiving thorough explanation on this study and fully understanding the explanation prior to participation in the study
•Patients who plan to receive colonoscopy procedure and meet any of the following conditions: Colon cancer screening, post-polypectomy surveillance, patients who are advised by a physician to take a colonoscopy exam

排除标准

•Patients for whom endoscopic submucosal dissection is planned
•Patients for whom polypectomy is difficult to perform due to antithrombotic therapy received etc.
•Patients who have to receive an urgent colonoscopy procedure
•Patients who underwent total colectomy of the large intestine
•Patients who are judged by a physician to be contraindicated for colonoscopy procedures
•Patients who have participated in another clinical study within the last 30 days