Evaluation of the Performance and Safety of VACUSERA® PRP Tubes in the Preparation of Autologous Platelet-Rich Plasma: A Prospective, Observational Medical Device Study (PMCF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Increasing platelet concentration
研究概览
简要总结
Study Design After the eligibility assessment during screening and obtaining a written informed consent form, the volunteers' demographic information and medical history will be recorded.
In addition to the hemogram and pregnancy test to be performed on the volunteers in this study, an additional tube (approximately 8 ml (±10%) for the VACUSERA® Single PRP Tube or approximately 7 ml (±10%) for the VACUSERA® Single Gel PRP Tube) will be used to obtain platelet-rich plasma (PRP). After centrifugation of the PRP tubes, the platelet (PLT) count in the resulting plasma will be analyzed, and the concentration increase in relation to whole blood will be evaluated.
详细描述
The study is a post-market clinical follow-up (PMCF) study aimed at proving the effectiveness and safety of PRP tubes that are already CE (European Conformity) certified and released on the market. After the eligibility assessment during screening and obtaining the written informed consent form, the demographic information and medical history of eligible volunteers will be recorded on a paper case report form.
The analysis conducted using the G-Power power test calculated that the number of patients to be included in the study is 194.In addition to the hemogram and pregnancy test to be performed on the volunteers in this study, an additional tube (approximately 8 ml (±10%) for the VACUSERA® Single PRP Tube or approximately 7 ml (±10%) for the VACUSERA® Single Gel PRP Tube) will be used to obtain platelet-rich plasma (PRP). After centrifugation of the PRP tubes, platelet (PLT) count will be performed on the obtained plasma, and the concentration increase relative to whole blood will be analyzed.
Screening Day (Day 1):
Volunteers will undergo a medical history review to check eligibility for inclusion in the study.
Analysis Day (Day 1):
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Increasing platelet concentration
时间窗: Day 1: Blood will be taken on the same day and sent for analysis for counting.
Approximately 8 ml (±10%) of blood will be collected to the PRP Tubes and approximately 7 ml (±10%) to the PRP Tube with Gel, and platelet (PLT) count will be performed on the obtained plasma, with the concentration increase relative to whole blood analyzed.
次要结局
未报告次要终点