NCT02221128已完成不适用
A Post Market Surveillance Study Evaluating the Safety and Effectiveness of PerClot to Control Mild Bleeding in Subjects Undergoing Endoscopic Sinus Surgery
CryoLife Europa1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of subjects who achieve of haemostasis after the application of PerClot
研究概览
简要总结
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Subjects having Endoscopic Sinus Surgery
- •Subjects who will have PerClot used as a haemostatic agent
- •Subjects willing and able to give consent
- •Subjects over 18 years old
排除标准
- •Subjects unable or unwilling to give consent for their data to be collected
结局指标
主要结局
Number of subjects who achieve of haemostasis after the application of PerClot
时间窗: intraoperatively
次要结局
- Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot(intraoperatively)
研究者
研究点 (1)
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