NCT01957904已完成不适用
Prospective, Multi-Center, Open-Label, Post-Market ArterX® Safety and Efficacy Study Protocol for Cardiac Indications
Tenaxis Medical, Inc.1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Number of subjects with immediate sealing of suture/staple line
研究概览
简要总结
The study is designed to confirm the acute safety and performance of the ArterX® Surgical Sealant as a hemostatic agent. The study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.
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
- •>18 years of age, Male or female If female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study.
- •The subject or guardian must provide written Informed Consent using a form that is reviewed and approved by the Ethics Committee.
- •The subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol.
- •The subject is determined by the surgeon to be at risk for poor hemostasis.
排除标准
- •Subject undergoing emergency surgery. Subject undergoing minimally invasive surgery. Subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up.
- •Subject has immune system disorders/immunodeficiency or immunosuppression. Subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days.
- •Subject is pregnant, may become pregnant or is currently breast feeding
结局指标
主要结局
Number of subjects with immediate sealing of suture/staple line
时间窗: during surgery
Immediate sealing of the suture/staple line at point of use upon release of the clamps, as evidenced by an absence of clinically significant bleeding as determined by physician investigator in procedures completed using the ArterX device.
次要结局
未报告次要终点
研究者
研究点 (1)
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