Post Market Clinical Follow-up Study on the Performance /Safety of Celsite® Venous Access Ports in Patients Who Need Repeated Venous Access
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- To assess the device's safety
研究概览
简要总结
The Celsite® Venous Access Ports System are intended to be used for repeated intravenous administration of, for example, chemotherapy, antibiotic and antiviral drugs, total parenteral nutrition, blood sampling or transfusion.
The objective is to assess the device's safety to deliver medication over the time in regard to the rate of adverse events related to the Celsite® access ports written in the IFU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient is at least 18 years old
- •Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Ethics Committee (EC) prior to all evaluations.
- •Patient for whom the access port placement has already been determined as the best treatment option within the regular planning of the patient's treatment in accordance with the IFU.
- •Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
排除标准
- •Patient for whom the technical and/ or clinical characteristics of the access port placement or use is outside the scope of the IFU.
- •Patient not followed-up in the center where the access port is implanted.
- •Pregnancy
- •Patient < 18 years of age
结局指标
主要结局
To assess the device's safety
时间窗: 2 years
The primary variable is the incidence/frequency of all adverse reactions/complications (intraoperative, postoperative, late etc.) which occurred during the study. Focus will be done on all adverse reactions/complications (intraoperative, postoperative, late etc.) related to the Celsite® access ports written in the IFU in comparison with the published data.
次要结局
未报告次要终点