NCT00987896已完成2 期
A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Safety and clinical feasibility of performing colonoscopy with megachannel
研究概览
简要总结
Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right colon.
The investigators want to conduct a multinational study to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right colon.
详细描述
Patients scheduled for colonoscopy with suspected right colonic polypoid lesions will be included. The prototype will loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. Time to cecum, total investigation time, clinical feasibility and complications will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •patients scheduled for colonoscopy with suspected large or multiple polys in the right colon
排除标准
- •previous abdominal surgery
- •history or currently diagnosed intra-abdominal cancer
- •patients presenting with unstable angina
- •drug abusers
- •pregnant women
- •patients with known colonic strictures
结局指标
主要结局
Safety and clinical feasibility of performing colonoscopy with megachannel
时间窗: during every single colonoscopy in the study
次要结局
未报告次要终点
研究者
研究点 (2)
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