NCT05869838已完成不适用
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 人开始时间: 2024年3月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Videos and still images of the colonoscopy
研究概览
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
结局指标
主要结局
Videos and still images of the colonoscopy
时间窗: during the procedure
Narrow band imaging (NBI) images and white-light images, video recordings of the colonoscopy
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
招募中
不适用
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic MethodsColorectal CancerNCT06515821Firalis SA4,100
已完成
不适用
Specimen Collection Study for H. Pylori TestingHelicobacter InfectionsNCT02970110Biomerica98
Unknown
不适用
Post Hoc Analysis and Clinical Data Collection for Subjects Tested With Brain Network Activation (BNA™) TechnologyHealthyCognitive ImpairmentNeurological DisorderNCT03699514ElMindA Ltd10,000
终止
不适用
Stool Sample Collection Protocol for Development of Screening Test for Colorectal Cancer and Other Digestive Tract CancersDigestive System DiseasesColonic DiseasesColorectal CancerColorectal NeoplasmsNCT02503631Exact Sciences Corporation397
已完成
不适用
Collection of Anatomical and Reference Data for Development of a Novel Non-Invasive Lung Hydration Status TechnologyHealthyNCT02426593Intersection Medical, Inc.100