Post Market Clinical Study - Evolution® Esophageal Stent Systems, Europe: Fully and Partially Covered
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 5
- 主要终点
- Number of participants with clinically relevant device migration
研究概览
简要总结
The aim of this post-market clinical follow-up study is to evaluate the continued safety and performance of the marketed Evolution® Esophageal Stent System (Partially- and Fully Covered).
详细描述
Cook Evolution® Esophageal Stent Post-Market Data Collection Study
A retrospective observational, multi-center, chart review study will be performed. Data specific to Cook Evolution® Esophageal Stent placement procedures from all consecutive patients who underwent stent placement with any of the stents at the participating sites between 1st January 2015 and 31st December 2020 (index period) will be collected. Research on the commercially available Cook Evolution® Esophageal Stents is being conducted to comply with the new medical device regulation, EU 2017/745, to assess the device for its continued safety and performance. To do this, Cook Research Incorporated is working with participating hospitals to collect pseudonymized (coded) personal health data. This study is in the interest of public health; to learn more about the necessary data processing, please visit the webpage below.
https://www.cookresearchinc.com/extranet/pdf/2054-55_Data_Protection_Notice.pdf
Spanish: https://www.cookresearchinc.com/extranet/pdf/2054-55_Data_Protection_Notice_ESP.pdf
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Patient has had at least one of the following stents implanted between 1st January 2018 and 31st December 2020*:
- •Evolution® Esophageal Stent System-Partially Covered
- •Evolution® Esophageal Stent System-Fully Covered
- •Evolution® Esophageal Stent System-Fully Covered
排除标准
- •1: Deceased retrospective patient who has set post-mortem instruction against processing of his/her health data
- •Patient or his/her legally authorized representative objects to collection and processing of his/her data, or not willing to sign not willing to sign an Informed consent, if it is required by the local EC committee. There may be local exemptions where consent is not a requirement or non-objection letters may replace informed consent processes.
结局指标
主要结局
Number of participants with clinically relevant device migration
时间窗: 6 months
Clinically relevant device migration is defined as stent migration requiring replacement of the stent due to degree of migration as well as clinical symptoms (i.e. an inability of the stent to perform its intended function).
次要结局
未报告次要终点