NL-OMON31912已完成3 期
on-randomised,open, multi-center trial evaluating feasibility and safety of Tachosil application on a colorectal anastomosis - Evaluation of Tachosil application on a colorectal anastomosis
ycomed0 个研究点目标入组 7 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •At screening
- •1. Has the patient given informed consent according to local requirements before any trial-related activities? A trial-related activity is any procedure that would not have been performed during the routine management of the subject
- •2. Is the subject 18 years of age or above?
- •3. Is the subject scheduled for elective resection of the rectum?
- •4. Is a colorectal anastomosis below the peritoneal reflexion planned?;For females of childbearing potential:
- •5. Does the patient use an acceptable contraceptive method (contraceptive pills, injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices, transdermal patches or intrauterine device (IUD))?
- •6. Is the urine pregnancy test negative?
排除标准
- •Exclusion Criteria
- •At screening
- •1. Is the subject scheduled for emergency resection of the rectum?
- •2. Does the subject suffer from inflammatory bowel diseases?
- •3. Does the subject have a history of hyper sensitivity reactions after application of human fibrinogen, human thrombin and/or collagen of any origin?
- •4. Has the subject participated in any other trial with an investigational medical product (IMP) or device within 30 days before inclusion in this trial?
- •5. Does the subject participate or plan to participate in another clinical trial during the trial period?
- •For females of childbearing potential:
- •7. Is the subject pregnant or breast feeding?;Peroperative
- •7. Was an anastomosis different from the one defined in the inclusion criterias performed?
- •8. Did the subject receive any fibrin sealant glue, excluding TachoSil, during surgery?
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