NCT01306864已完成不适用
Clinical Evaluation of Hemospray: Hemostasis of Active GI Luminal Tract Bleeding
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 12
- 主要终点
- Proportion of patients with further bleed
研究概览
简要总结
The objective of this study is to show that Hemospray is effective in achieving initial hemostasis and documenting rate of further bleed when compared to standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Bleeding peptic ulcer
排除标准
- •Patient is: < 18 years of age
- •Patient is unable to consent
- •Patient is contraindicated to undergo endoscopy
- •Patient has: coagulopathy, altered post surgical anatomy of the stomach, previously placed intrahepatic portosystemic shunt
- •Patient is pregnant or lactating
- •Patinet has an INR > 2.5
研究组 & 干预措施
Hemospray Treatment
Experimental
Hemospray Kit
干预措施: Hemospray Kit (Device)
结局指标
主要结局
Proportion of patients with further bleed
时间窗: 72 Hours
次要结局
- Proportion of patients with initial hemostasis(At the conclusion of the index procedure)
研究者
研究点 (12)
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