Clinical Evaluation of Hemospray in Hemostasis of Active Variceal Bleeding
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
The objective of this study is to assess the effectiveness of Hemospray in achieving initial hemostasis and decreased rate of re-bleeding in patients of acute variceal bleeding.
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
- 未提供
排除标准
- •Patient is: < 18 years of age
- •Unable to consent
- •Contraindicated to undergo endoscopy,
- •Already hospitalized for another illness
- •Pregnant or lactating
- •Patients with altered post-surgical anatomy of the stomach
- •Previously placed intrahepatic portosystemic shunt
- •Patient treated by other endoscopic or surgical modalities within 7 days prior to the intended application of Hemospray
研究组 & 干预措施
Hemospray Group
Hemospray device consists of a syringe containing the Hemospray powder (21 g per syringe), a delivery catheter that will be inserted into the working channel of the endoscope, and an introducer handle with a built-in carbon dioxide canister to propel the Hemospray powder out of the catheter.
In addition to Hemospray device any other required endoscopic accessories can be used during the procedure.
干预措施: Hemospray (Device)
结局指标
主要结局
Safety
时间窗: 24 hours
Safety will be characterized by the incidence of all Adverse Device Effects (ADEs), non-serious and serious, possibly related to or related to the procedure and/or device that are experienced by study participants.
次要结局
- Effectiveness(24 hours)
研究者
Mostafa Ibrahim
Gastroenterologist
Theodor Bilharz Research Institute