NCT04979962已完成不适用
Colorectal Polyp Detection Comparing Computer Assisted Colonoscopy With Conventional Colonoscopy
Fujifilm Medical Systems USA, Inc.18 个研究点 分布在 1 个国家目标入组 1,162 人开始时间: 2021年11月24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
- 1,162
- 试验地点
- 18
- 主要终点
- Adenoma per colonoscopy (APC)
研究概览
简要总结
This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
Patients will be randomized 1:1, inspection with computer assisted colonoscopy: inspection with conventional colonoscopy.
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
- •Patients aged 45 or older
- •Patients who can provide an informed consent
排除标准
- •Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
- •Patients who are pregnant or are planning pregnancy during study period
- •Patients who are not able to or refuse to give informed consent
结局指标
主要结局
Adenoma per colonoscopy (APC)
时间窗: 1 day/procedure
Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies
次要结局
- Positive predictive value (PPV)(1 day/procedure)
- Adenoma detection rate (ADR)(1 day/procedure)
研究者
研究点 (18)
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