The Clinical Utility of Overtube Use at the Time of Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Number of Patients With Persistent or Recurrent Bleeding
研究概览
简要总结
Endoscopy has become a vital part of the gastroenterologist's evaluation and treatment of disorders involving the gastrointestinal (GI) tract. The small bowel is an area of the GI tract, which can prove difficult to visualize during an endoscopy specifically designed to evaluate it, termed enteroscopy. Thus, the FDA has approved overtubes, such as the Endo-Ease® spiral overtube (Spirus Medical, Inc.) or EnteroPro® balloon overtube (Olympus Medical, Inc.), to facilitate passage of the endoscope through the GI tract. The aims of the study are to evaluate the efficiency of an overtube system for visualization of small bowel. The hypothesis is that this will permit more complete and efficient evaluation of the small intestine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Subjects ≥ 18 years.
- •Have an indication for enteroscopy as determined by the patient's physicians. These indications include, but are not limited to, obscure gastrointestinal bleeding, malabsorption, suspected small bowel tumor, small bowel strictures, small bowel ulceration, and abnormal imaging of the small bowel.
- •Scheduled to undergo enteroscopy at the University of Florida, Gainesville, Florida, as medically indicated.
- •Subject must be able to give informed consent.
排除标准
- •Platelets < 75,
- •NSAIDS within 48 hours of procedure.
- •Esophageal stricture.
- •Inability to give informed consent.
结局指标
主要结局
Number of Patients With Persistent or Recurrent Bleeding
时间窗: up to 6 yrs after after the endoscopy
The number of patients that had persistent or recurrent GI bleeding after spiral enteroscopy.
次要结局
未报告次要终点