A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Delivery System Success Rate (DSSR)
研究概览
简要总结
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.
详细描述
Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 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
- •Healthy males
排除标准
- •Inability to read English;
- •physical limitations preventing participant from operating the syringe
研究组 & 干预措施
Group 1
干预措施: dual-chamber syringe (Other)
结局指标
主要结局
Delivery System Success Rate (DSSR)
时间窗: Day 1
DSSR was defined as percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Dual Chamber Delivery System when relying on the modified Instructions for Use (IFU). The process was considered successful if the attempt was observed and documented by study personnel AND the participant didn't receive any operational/"hands on" demonstration on how to operate the plunger from study personnel AND after performing all preparatory steps, the participant was able to expel the dose to the selected plunger stop-point without any unexpected interruption.
次要结局
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8(Day 1)
- Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9(Day 1)
- Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful?(Day 1)
- Number of Participants With Categorical Responses to the PAT: Instructions Provided Were Clear?(Day 1)
- Number of Participants With Categorical Responses to the PAT: Most Difficult Step?(Day 1)
- Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use?(Day 1)
- Number of Participants Providing Responses to Any Question on the PAT(Day 1)
- Time Required to Perform Segments 1 to 5(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2(Day 1)
- Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16(Day 1)
- Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17(Day 1)