NL-OMON55236
已完成
不适用
Prospective, multicenter study to evaluate the Safety and performance of a syntHetic tissue sealant in reducing fluid lEakage following elective hepatobiLiary anD pancreatic Surgery - SHIELDS
Polyganics BV, Groningen0 个研究点目标入组 12 人待定
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Fluid leakage following elective hepatobiliary and pancreatic surgery / leakage of bile and pancreatic juices after surgery
- 发起方
- Polyganics BV, Groningen
- 入组人数
- 12
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Preoperative
- •\- Subjects who are able to provide a written informed consent prior to
- •participating in the clinical investigation
- •\- Subjects who are \>\= 18 years old.
- •\- Subjects who are able to comply with the follow\-up or other study requirements
- •\- Subjects who are planned for an elective hepatic resection surgery or
- •elective distal pancreatectomy surgery
- •Intraoperative
- •\- Patch is applied manually (during open procedure, conversion procedure, or
- •laparoscopic assisted procedure)
排除标准
- •Preoperative
- •\- Female subjects who are pregnant and/or breastfeeding
- •\- Subjects with a known allergy to any of the components of the Sealing Device
- •(Polyurethane sheet with DC\-Green \#6 dye and Polyurethane matrix foam with
- •8\-Arm\-PEG40k succinimidyl carbonate adhesive and Disodium Hydrogen Phosphate)
- •\- Subjects with bleeding disorders requiring anti\-coagulation medication
- •(except acetylsalicylic acid)
- •\- Subjects who receive double\-anti coagulation
- •\- Subjects who receive peritoneal dialysis
- •\- Subjects with a presence of systemic infection
结局指标
主要结局
未指定
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