NCT01008605已完成3 期
Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
研究概览
简要总结
The purpose of this study is to demonstrate the usability of the system.
详细描述
demonstrate usability
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 40 to 70
排除标准
- •Prior syringe skills
结局指标
主要结局
Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
时间窗: Day 1
Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.
次要结局
- Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3(Day 1)
- Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2(Day 1)
- Number of Participants Providing Comments to Any Question on the Participant Assessment Tool(Day 1)
- Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1(Day 1)
- Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4(Day 1)
- Time Required to Perform Each Step While Using the Caverject Impulse Delivery System(Day 1)
研究者
研究点 (3)
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