NCT01719172已完成不适用
A Prospective, Multi-Center, Single-Arm Study of the Veriset™ Hemostatic Patch in Controlling Bleeding in Soft Tissue
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
研究概览
简要总结
The objective of this study is to determine the safety of Veriset™ Hemostatic Patch when used during non-emergent, open, soft tissue surgery where a topical hemostatic agent would be used.
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
- •Subject or authorized representative has provided informed consent.
- •Subject is ≥ 18 years old.
- •Subject is scheduled for nonemergent surgery where a topical hemostatic agent would be used to control bleeding emanating from a tissue bed following organ dissection or removal or a bleeding tumor tissue bed following resection or dissection, via an open approach.
- •Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
- •Subject has an appropriate Target Bleeding Site (TBS) during the surgical procedure.
- •TBS bleeding assessment is Type 2 or 3 (refer to table in protocol).
排除标准
- •Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
- •Subject has an estimated life expectancy of less than 6 months.
- •Subject is scheduled for another planned surgery and the subsequent surgery would jeopardize the previous application of study treatment.
- •Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
- •Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with the study.
- •Subject has an active local infection at the TBS.
- •The investigator determines that participation in the study may jeopardize teh safety or welfare of the subject.
研究组 & 干预措施
Veriset™ Hemostatic Patch
Experimental
Topical hemostat
干预措施: Veriset™ Hemostatic Patch (Device)
结局指标
主要结局
Percent Success in Obtaining Hemostasis Following Veriset Hemostatic Patch Treatment
时间窗: Intra-operative (Day 0)
Success will be defined as hemostasis obtained within 5 minutes. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.
次要结局
- Proportion of Subjects Who Achieve Hemostasis Within 1 Minute(Intra-operative (Day 0))
- Median Time to Achieve Hemostasis(Intra-operative (Day 0))
研究者
研究点 (3)
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