EndoRings Versus Standard Colonoscopy for Adenoma Detection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 8
- 主要终点
- Adenoma detection rate
研究概览
简要总结
Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.
EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •indication for colonoscopy (screening, surveillance, diagnostic)
- •age ≥ 45 years
- •ability to give informed consent
排除标准
- •pregnancy
- •age <45 years
- •known colonic strictures
- •chronic inflammatory bowel disease
- •active inflammation
- •s/p colonic resection
- •bleeding disorder
研究组 & 干预措施
EndoRings
Colonoscopy is performed with the EndoRings attached
干预措施: EndoRings (Device)
Standard Colonoscopy
Standard colonoscopy without any additional devices
干预措施: Standard colonoscopy (Device)
结局指标
主要结局
Adenoma detection rate
时间窗: during colonoscopy
次要结局
未报告次要终点