NCT03600168Unknown不适用
A Multi-center, Single Arm Post-market Clinical Study to Confirm Safety and Performance of Purastat Absorbable Haemostatic Material for the Management of Bleeding After Open Liver Resection
3-D Matrix Europe SAS1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年8月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total Time-To-Haemostasis
研究概览
简要总结
The objective of this post-market clinical follow-up study is to collect medical information on patients implanted with PuraStat®, according to each participating institution's procedures and standards of care.
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
- •Male or female patient ≥ 18 years old
- •Subject have been informed and understand the nature and extent of the study, agree to its provisions and have provided written approved informed consent
- •Patient undergoing elective primary or redo open liver resection for hepatic colorectal metastases with a curative intent
- •Subject, who, in the opinion of the Clinical Investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up.
排除标准
- •Known allergy or hypersensitivity to any component of the investigational treatment PuraStat®
- •Pregnant or interested in becoming pregnant during the duration of the study, or breast feeding
- •Concurrent participation in another clinical study with a medical device or medicinal product with interfering endpoints
结局指标
主要结局
Total Time-To-Haemostasis
时间窗: Intraoperatively
Total Time-To-Haemostasis will be intraoperatively measured (minutes, seconds)
次要结局
未报告次要终点
研究者
研究点 (1)
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