NCT04884581已完成不适用
The CHANGE Study: Characterization Helping the Assessment of Colorectal Neoplasia in Gastrointestinal Endoscopy
Nuovo Regina Margherita Hospital1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2021年5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
- 165
- 试验地点
- 1
- 主要终点
- Negative Predictive Value (NPV)
研究概览
简要总结
This is a post-marketing, single-arm, prospective study investigating the use of GI Genius CADx device in the real-time characterization of colorectal polyps (i.e. prediction of their histology during the colonoscopy). Patients enrolled will undergo a standard white-light colonoscopy with the support of the latest version of the CE-marked GI Genius CADx device. Colonoscopy will be performed according to the standard practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 40 years or older undergoing screening colonoscopy for CRC
- •Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation
排除标准
- •subjects at high risk for colorectal cancer
- •subjects with a personal history of CRC, IBD or hereditary polyposis or non-polyposis syndromes
- •patients with previous resection of the sigmoid rectum
- •patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings
- •patients who perform an emergency colonoscopy
结局指标
主要结局
Negative Predictive Value (NPV)
时间窗: 4 months
Negative Predictive Value (NPV) of GI Genius CADx optical diagnosis on diminutive (≤5 mm) rectosigmoid polyps
次要结局
未报告次要终点
研究者
Cesare Hassan
MD
Nuovo Regina Margherita Hospital
研究点 (1)
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