NCT02034929已完成不适用
A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
Helios Albert-Schweitzer-Klinik Northeim8 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- adenoma detection rate
研究概览
简要总结
The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.
The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.
The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.
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
- •indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent
排除标准
- •pregnancy
- •age<18 years
- •known colonic strictures
- •chronic inflammatory bowel disease
- •active inflammation
- •s/p colonic resection
研究组 & 干预措施
Standard colonoscopy
Active Comparator
Standard Colonoscopy
干预措施: Standard colonoscopy (Device)
Endocuff-assisted colonoscopy
Active Comparator
Endocuff-assisted colonoscopy
干预措施: EndoCuff-assisted colonoscopy (Device)
结局指标
主要结局
adenoma detection rate
时间窗: 25 minutes
completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.
次要结局
- total colonoscopy rate(25 minutes)
- procedure time(25 Minutes)
- polyp detection rate(1 Week)
- number of LGIN and HGIN adenomas detected(one week)
- polyp distribution(25 minutes)
- ileum intubation rate(10 minutes)
- withdrawal time(10 Minutes)
- adverse events(25 minutes)
研究者
Tobias Meister
PD Dr. med.
Helios Albert-Schweitzer-Klinik Northeim
研究点 (8)
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