Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 4
- 主要终点
- 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes
研究概览
简要总结
The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
详细描述
A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United States.
The estimated duration of the study is approximately 8 months from the time of first subject enrollment to the last subject enrollment. Enrollment occurs intraoperatively after confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative performance assessments and then will be discontinued from the study after completion of the intraoperative visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preoperative Inclusion Criteria
- •Subject is undergoing a non-emergent cardiothoracic surgery; and
- •Subject or an authorized legal representative is willing and able to give prior written informed consent for study participation.
- •Preoperative
排除标准
- •Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
- •Subject has religious or other objections to porcine or bovine components; and
- •Subject is not appropriate for inclusion in the clinical study, per the medical opinion of the Investigator.
- •Intraoperative Inclusion Criteria
- •Subject does not have an active or suspected infection at the surgical site;
- •Subject in whom the Investigator is able to identify a Target Bleeding Site (TBS) for which any applicable conventional means for hemostasis are ineffective or impractical; and
- •Subject has a TBS with minimal, mild, or moderate bleeding
研究组 & 干预措施
HEMOBLAST Bellows (Hemostatic Device)
Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use
干预措施: HEMOBLAST Bellows (Device)
FLOSEAL (Hemostatic Device)
Bleeding sites will be treated with FLOSEAL per its approved Indications for Use
干预措施: FLOSEAL (Device)
结局指标
主要结局
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes
时间窗: Intraoperative
The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.
次要结局
- 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes(Intraoperative)