NCT02099435已完成不适用
A Prospective Observational Cohort Study of Hemospray for Lower Gastrointestinal Hemorrhage (APPROACH LGI)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Percentage of device related adverse events
研究概览
简要总结
This study is to evaluate the performance of Hemospray for the teatment of nonvariceal lower gastrointestinal bleeding.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient in which Hemospray is used to treat an endoscopically confirmed nonvariceal lower GI bleed requiring hemostasis
排除标准
- •Less than 19 years old
- •Unwilling or unable to sign and date the informed consent
- •Pregnant, lactating or planning to become pregnant within 30 days of the procedure
- •Contraindicated to undergo colonoscopy
- •Medical/Endoscopic Exclusion Criteria
- •Actual or suspected lower GI perforation or fistula
- •Bleeding originating from inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- •Actual or suspected ischemic colitis or infectious colitis
- •Unable to visualize site of active bleeding (such as suspected diverticular bleed where source is unable to be identified)
- •Unable to treat active site of bleeding (e.g., bleeding site cannot be reached by the colonoscope)
结局指标
主要结局
Percentage of device related adverse events
时间窗: 30 days
次要结局
- Percentage of hemostasis of lower GI bleeds originating from multiple sources(30 days)
- Percentage of recurrent bleeding that occurs outside the blood vessel(30 days)
- All cause mortality(30 days)
研究者
研究点 (4)
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