The purpose of this study is to demonstrate the usability of the system.
demonstrate usability
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
48
syringe
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
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.
Time frame: Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Time frame: Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
Participant Assessment Tool, Question 2: Instructions provided were clear? Participant responses were reported as follows: Very Clear, Somewhat Clear, Not Very Clear, Not Clear At All.
Time frame: Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.
Time frame: Day 1
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult
Time frame: Day 1
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.
Time frame: Day 1
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.
Time frame: Day 1