KCT0000490尚未招募未知
A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
Johnson & Johnson Medical Korea0 个研究点目标入组 28 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Preoperative:
- •1) Subjects undergoing primary elective lower anterior resection with a stapled end-toend
- •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:
- •1) Confirmed distance of anastomosis is =12cm from the anal verge, as measured using
- •a rigid rectoscope.
- •2) Anastomosis with a successful leak test.
排除标准
- •Preoperative:
- •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 for the 90 day follow up period after surgery.
- •Intraoperative:
- •1) Subject requiring protective ostomy;
- •2) Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures.
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