EUCTR2011-005479-17-BE进行中（未招募）1 期
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques - The EVICEL® GI Study
Ethicon Inc., a Johnson & Johnson Co.0 个研究点目标入组 150 人开始时间: 2012年4月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Preoperative:
- •1) Subjects undergoing primary elective lower anterior resection with a stapled end-to-end or end-to-side anastomosis;
- •2) Subjects = 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures;
- •Intraoperative:
- •3) Confirmed distance of anastomosis is =12cm from the anal verge, as measured using a rigid scope or non-flexible scope alternative.
- •4) Anastomosis with a successful leak test.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •Pre-operative:
- •1) Avastin use within 30 days prior to surgery;
- •2) Known hypersensitivity to the human blood products or the components of the investigational product;
- •3) Female subjects who are pregnant or nursing;
- •4) 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.
- •Intra-operative:
- •5) Subject requiring protective ostomy;
- •6) Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures.
- •7) Use of any fibrin sealant for haemostasis during the surgical procedure.
研究者
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