Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 561
- 试验地点
- 10
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)
详细描述
The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Colonoscopy independent from indication
- •Patient is able to provide informed consent for the procedure
排除标准
- •Inflammatory Bowel Disease stenosis
- •Pregnant of nursing patient
- •Acute diverticulitis
- •Active Inflammatory Bowel Disease
- •Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)
结局指标
主要结局
Adenoma detection rate
时间窗: 1 year
Proportion of patients having at least one adenoma
Polyp detection rate
时间窗: 1 year
Proportion of patients having at least one adenoma
次要结局
- perforation(one day)
- Ileum intubation rate(one year)
- withdrawal time(one day)
- mucosal laceration(one day)
- severe bleeding(one day)
- Bowel preparation result(one day)
- Coecum intubation rate(one year)
- Coecum intubation time(one day)
研究者
Tobias Meister
Prof. Dr. med. Tobias Meister
Helios Albert-Schweitzer-Klinik Northeim