Prospective, Monocentric Observational Study on the Clinical Use and Patient Satisfaction of Pfmmedical Implantable Vascular Access Ports
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Patients satisfaction
研究概览
简要总结
Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of 6 months. The focus is on patient reported satisfaction, clinical application, and complication rates.
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
- •Age: ≥ 18 years.
- •Medical indication for port catheter implantation.
- •The patient is mentally able to understand the nature, aims and possible consequences of the PMCF study.
- •Patient information has been provided and written consent exists.
排除标准
- •Contraindications according to the manufacturer´s instructions for use (IFU).
- •The patient is institutionalised by court or official order (MPDG §27).
- •Patient participates in another operative clinical investigation if it relates to the area of port devices and/or influences the primary endpoint of the PMCF study.
- •Patients who currently already have a port implanted.
结局指标
主要结局
Patients satisfaction
时间窗: 6 months after port implantation
The study hypothesis is that the patients' satisfaction after the study intervention is not worse than the satisfaction identified in the current literature. Satisfaction is determined using the patient questionnaire (6 months after implantation). The following 4 domains of the validated questionnaire by Nagel et.al., 2012 are considered as relevant for the clinical outcome: * Overall, how satisfied are you with the port system? * In a similar situation, would you choose the port again? * How satisfied are you with the cosmetic result? * Does the port cause pain?
次要结局
未报告次要终点