NCT01184690Unknown4 期
Prospective Trial Comparing Single-Operator and Dual-Operator Double-balloon Endoscopy in Patients With Small-Bowel Disorders
适应症
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- completion whether the complete enteroscopy is achieved?
研究概览
简要总结
Double-balloon endoscopy (DBE) is a new device that allows diagnosis and treatment throughout the entire small intestine. Although the originally described method requires two operators, the investigators have recently developed a method to perform DBE by a single operator. The investigators here assessed the clinical usefulness of this one-person method in comparison to the conventional two-person DBE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected or known small-bowel disease
排除标准
- •coagulation disorders
- •prior surgery of the small bowel and colon
结局指标
主要结局
completion whether the complete enteroscopy is achieved?
时间窗: 2 hours
The completion rate for examination of the entire small intestine
lesion-discovery
时间窗: 2 hours
lesion-discovery rate
次要结局
- observation time(2 hours)
- Number of Participants with Adverse Events(2 days)
研究者
研究点 (1)
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