DRKS00016048招募中未知
A prospective feasibility study on the treatment of gastrointestinal leakage by the use of combination of covered nitinol stent and negative pressure wound treatment - VAC-Stent
Klinik für Viszeral-, Tumor-, Transplantations- und Gefäßchirurgie, Klinikum Köln-Merheim0 个研究点目标入组 30 人开始时间: 2019年1月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Presence of a written consent of the patient
- •Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus
- •Accessibility of the leakage with the delivery system of the VAC stent
排除标准
- •Simultaneous participation in other interventional trials
- •Endoscopic inaccessibility of the affected section
- •Full anticoagulation with INR > 1.5 and/or PTT > 50 sec, or platelets < 20.000/µl (after therapeutic correction an inclusion is possible)
- •Unstable patients with a severe septic condition who require an immediate operation
- •ileus image with constant vomiting (after gastric tube and gastric emptyingan inclusion is possible)
- •Persons who are in a dependency / employment relationship with the sponsor or investigator
- •Accommodation in an institution under court or administrative order
研究者
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