Registry Study for the Use of HEMOBLAST™ Bellows in Abdominoplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Achievement of Hemostasis at the Target Bleeding Site
研究概览
简要总结
The purpose of this post-market observational registry is to collect additional data on the safety and efficacy of the HEMOBLAST™ Bellows device in abdominoplasty procedures.
详细描述
A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.
Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 6 months from the time of first subject enrollment to completion of the last subject follow up.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is undergoing a primary full abdominoplasty procedure without concomitant liposuction; and
- •Patient is willing and able to give written informed consent for registry participation
- •Preoperative
排除标准
- •Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and
- •Patient has religious or other objections to porcine, bovine, or human components
- •Intraoperative Inclusion Criteria
- •Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
- •The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indications for Use
结局指标
主要结局
Achievement of Hemostasis at the Target Bleeding Site
时间窗: Intraoperatively, expected within 3-10 minutes of application
The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed.
次要结局
- Incidence of Serious Adverse Device Effects (SADEs)(Through study completion, on average 14 days post-surgery)
- Incidence of Unanticipated Serious Adverse Device Effects (UADEs)(Through study completion, on average 14 days post-surgery)