Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
研究概览
详细说明
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 10 months from the time of first subject enrollment to completion of the last subject follow up.
研究类型
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Preoperative Inclusion Criteria:
- Patient is undergoing a unilateral total knee arthroplasty procedure; and
- Patient is willing and able to give written informed consent for registry participation.
Preoperative Exclusion Criteria:
- 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 Indication for Use.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Total Knee Arthroplasty Patients
Patients undergoing primary or revision total knee arthroplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical
|
HEMOBLAST™ Bellows 止血剂由一个预先装有 1.65 克粉末的波纹管组成，该粉末由胶原蛋白、硫酸软骨素和凝血酶 (1500 IU) 组成。
HEMOBLAST™ Bellows 在外科手术中作为止血的辅助手段，当通过常规手术控制最小、轻度和中度出血无效或不切实际时，神经外科、眼科和泌尿外科手术除外。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Achievement of Hemostasis at the Target Bleeding Site
大体时间：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
|
Intraoperatively, expected within 3-10 minutes of application
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of Serious Adverse Device Effects (SADEs)
大体时间：Through study completion, on average 1-2 days post-surgery
|
The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified
|
Through study completion, on average 1-2 days post-surgery
|
|
Incidence of Unanticipated Serious Adverse Device Effects (UADEs)
大体时间：Through study completion, on average 1-2 days post-surgery
|
The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device
|
Through study completion, on average 1-2 days post-surgery
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.