A Multicenter Observational Study to Evaluate Outcomes of EmboCube Gelatin Embolization to Control Bleeding or Hemorrhaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 5
- 主要终点
- Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours
研究概览
简要总结
This is a multicenter, observational study of the use of EmboCube Embolization Gelatin to control hemorrhaging and bleeding. The study is designed to enable the collection, analysis, and reporting of data from "real-world" use of EmboCube used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval.
Data collection will include that relating to safety and effectiveness and the period of observation during which data will be collected will extend from the index procedure through 28 days post procedure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Subject requires embolization and is suitable for treatment with EmboCube in accordance with device Instructions For Use for the treatment of bleeding or hemorrhage.
- •Subject provides written informed consent to study data collection.
排除标准
- •Bleeding site in the neck, head, or brain.
- •Subject has co-morbidity with survival prognosis of less than 30 days, in the opinion of the treating physician
- •In the investigator's opinion, participation in the study may not be in the subject's best interest.
结局指标
主要结局
Number of Participants With Clinical Success: Cessation of Bleeding up to 24 Hours
时间窗: 24 hours
The primary performance endpoint will be clinical success defined as cessation of bleeding post-embolization and absence of rebleeding at the treated site requiring reintervention (repeat embolization or additional surgery), within 24 hours.
Number of Participants Without Device and Procedure-related AEs (Incidence of Device and Procedure-related AEs)
时间窗: 24 hours
Absence of unanticipated serious adverse device effects within 24 hours.
次要结局
未报告次要终点