A Retrospective, Observational, Multicenter Study to Evaluate the Safety and Performance of POLYSITE® and SEESITE® Implantable Ports
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 3
- 主要终点
- Associate Performance : correct device insertion assess by Radiological endpoint
研究概览
简要总结
The purpose of this study is to evaluate performance and safety of POLYSITE® and SEESITE® implantable ports allowing repeated and prolonged access to the venous system for the administration of chemotherapy, antibiotics, antiviral drugs, parenteral nutrition, and for blood transfusion or blood derivatives transfusion.
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 paediatric population
- •Patient who received the implantation of any POLYSITE® or SEESITE® implantable port referenced in the Annex 1 of the current protocol between 1-JAN-2018 and 31-DEC-2020
排除标准
- •Patient who refused the data collection according to GDPR regulation applicable in France
- •Patient who received the implantation of another device than those presented in Annex 1 of the current protocol.
结局指标
主要结局
Associate Performance : correct device insertion assess by Radiological endpoint
时间窗: Peri-procedure
percentage of patients with correct insertion into venous access objectively assessed via radiography, ECG or echography measurement
Performance : success of the insertion and placement of the implantable port.
时间窗: Peri-procedure
evaluation of the success of the insertion and placement of the implantable port.
Associate Performance : correct device insertion assess Clinical endpoint
时间窗: Peri-procedure
percentage of patients with correct placement objectively assessed by clinical observation
Per-procedure Safety
时间窗: 30 Days
evaluation of the safety of the implantable ports
Associated Safety : rate of complications
时间窗: 30 days
measurement of the rate of complications reported during the short-term period of 30 days after the implantation date. As example, the following short-term complications will be looked at: infections, bleeding and hematoma, pneumothorax, hemothorax and pleural effusion, pain.
次要结局
- Safety: perioperative time(5 years)
- Safety Long Term period: complications(5 years)
- Performance : evaluation of the device performance(5 years)
- device failure(5 years)
- Safety FU period: Device Failure Removal(5 years)
- Safety Long Term period: Device Failure Removal(5 years)
- Emergent Risks(5 years)