NCT03962179Unknown不适用
VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
University Hospital of Cologne2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年9月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Technique - % of patients with successful implantation of VACStent
研究概览
简要总结
Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
详细描述
The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
- •Accessibility of the leak with the delivery system of the VAC stent
排除标准
- •Simultaneous participation in other interventional exams
- •Endoscopic inaccessibility of the affected section
- •Full anticoagulation with international normalized ratio (INR) > 1.5 and / or partial thromboplastin time (PTT) > 50 sec, or platelets <20.000 / μl (after therapeutic correction an inclusion is possible)
- •Unstable patients with severe septic disease, who have a clinical history
- •Assessment an immediate operation for safe focus switch-off requires
- •Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
- •Persons who are in a dependency / employment relationship with the sponsor or examiner stand
- •Accommodation in an institution for judicial or regulatory purposes arrangement
结局指标
主要结局
Technique - % of patients with successful implantation of VACStent
时间窗: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
% of patients with successful implantation of VACStent
次要结局
- Healing of leak - % of patients with successful implantation of VACStent(From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months)
- Treatment of sepsis(From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months)
- Migration rate(From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months)
- Bleeding(From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months)
- Arrosion of tissue structures(From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months)
- Sealing of leak - % of patients with successful implantation of VACStent(From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months)
研究者
Seung-Hun Chon
PI
University Hospital of Cologne
研究点 (2)
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