Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 3
- 主要终点
- The true failure rate of DropSafe safety pen needle.
研究概览
简要总结
A simulated clinical use testing on the DropSafe safety pen needle
详细描述
This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Minimum of age
- •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.
- •Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).
排除标准
- •If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.
研究组 & 干预措施
simulation of injection
The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.
干预措施: DropSafe safety pen needle (Device)
结局指标
主要结局
The true failure rate of DropSafe safety pen needle.
时间窗: At time of testing, about an hour
The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.
次要结局
- Ease of use(At time of testing, about an hour)
- Ease of understanding the instructions for use(At time of testing, about an hour)
- Problems associated with the device(At time of testing, about an hour)
- Ability to follow the instructions for use(At time of testing, about an hour)