NCT00598130已完成2 期
A Prospective, Randomized, Single-Blind, Standard Care Controlled, Multi-Center, Phase II Study Evaluating the Safety and Hemostatic Efficacy of Fibrin Fleece in Partial Nephrectomy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Proportion of successes at 10 minutes following randomization
研究概览
简要总结
This is a prospective, randomized, single blind, standard care- controlled study, which will include a total of 30 patients divided into two treatment arms: First are: patents who will be treated in accordance with standard of care. Second arm: patients for which the Fibrin Fleece will be applied directly on the active bleeding site.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective open partial nephrectomy
- •Patients must be willing to participate in the study, and provide written informed consent
排除标准
- •Patients with a tumor diameter greater than 4 cm
- •Any additional surgical intervention other than partial nephrectomy
- •Patients with only one functional kidney
- •Patients with known intolerance to blood products or other components of the product
结局指标
主要结局
Proportion of successes at 10 minutes following randomization
时间窗: 10 minutes
次要结局
- Proportion of successes at 5 minutes following randomization(5 minutes)
研究者
研究点 (4)
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