NCT01589822已完成2 期
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 214
- 试验地点
- 22
- 主要终点
- Absence of Gastrointestinal (GI) Leak
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) for use as an adjunct to gastrointestinal (GI) surgery.
详细描述
This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL® when used as an adjunct to gastrointestinal (GI) surgery.
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
- 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
- •Subjects undergoing primary elective GI surgery
- •Subjects ≥ 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures
排除标准
- •Avastin use within 30 days prior to surgery;
- •Known hypersensitivity to the human blood products or the components of the investigational product;
- •Female subjects who are pregnant or nursing;
- •Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
研究组 & 干预措施
Standard of Care
No Intervention
Standard surgical technique for GI anastomosis.
Experimental: EVICEL Fibrin Sealant: Non-Randomized
Experimental
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen
干预措施: EVICEL Fibrin Sealant (Biological)
EVICEL Fibrin Sealant: Randomized
Experimental
EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.
干预措施: EVICEL Fibrin Sealant (Biological)
结局指标
主要结局
Absence of Gastrointestinal (GI) Leak
时间窗: 40 days
次要结局
- Incidence of Adverse Events(up to Day 90)
- Incidence of GI Leak(90 days)
- Incidence of Stricture(up to Day 90)
研究者
研究点 (22)
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