Caverject User Study

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the usability of the system.

Detailed Description
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demonstrate usability

Official Title
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Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Other: delivery system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 to 70 Exclusion Criteria: Prior syringe skills

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caverject Impulse<br>representative users | Other: delivery system<br>* syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | Day 1 | 
| 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. | 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erectile Dysfunction