NCT02663635已完成3 期
Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange
研究概览
简要总结
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
详细描述
This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The Evaluator must be:
- •Minimum of age 18
- •Able to understand and provide signed consent for the study
- •Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires
- •Have no concerns about the ability to perform the simulated injections
- •With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)
排除标准
- •If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.
结局指标
主要结局
The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange
时间窗: At time of testing, day 1
次要结局
- Evaluator assessment of device handling(At time of testing, day 1)
- Ease of Use(At time of testing, day 1)
- Evaluator assessment of instructions(At time of testing, day 1)
- Evaluator assessment of improvement of device over predecessor device(At time of testing, day 1)
研究者
研究点 (2)
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