A Retrospective, Observational, Monocenter, Study to Describe the Utilization and Overall Safety and Performance of POLYSITE®/SEESITE® Implantable Ports
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Identification of veins selected
研究概览
简要总结
This study is a retrospective, observational, monocenter case series. The purpose of this study is to collect clinical data to describe the use of POLYSITE® and SEESITE® devices and verify overall safety and performance. This study is part of the Post-Market Clinical Follow-up (PMCF) activities of the PEROUSE MEDICAL manufacturer.
The primary data source for this study was patient's medical records from a French Hospital. The study population was defined as all patients who did receive POLYSITE® and SEESITE®. Data from a minimum of 50 patients were planned for the statistical review.
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
- •Adult and pediatric population
- •Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1st October 2016 and 31st December 2017
排除标准
- •Patient who refused the data collection according to RGPD regulation applicable in France
- •Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
- •Patient who received the implantation of a POLYSITE® or SEESITE® implantable port after 31st December 2017
结局指标
主要结局
Identification of veins selected
时间窗: 30 days
insertion's location of the POLYSITE®/SEESITE® implantable port
rate of peri-operative complication
时间窗: Peri-operative procedure
number of complications between the implantation of the device and the first use (as example infections related to manipulation)
次要结局
- Rate of procedural success(Peri-operative procedure)
- short-term complication(30 Days)
- rate of long-term complications(5 years)
- type of treatments administered(5 years)