Caverject User Study

Overview

The purpose of this study is to demonstrate the usability of the system.

Full Title of Study: “Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2011

Detailed Description

demonstrate usability

Interventions

  • Other: delivery system
    • syringe

Arms, Groups and Cohorts

  • Experimental: Caverject Impulse
    • representative users

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System
    • Time Frame: 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.

Secondary Measures

  • Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1
    • Time Frame: Day 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.
  • Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2
    • Time Frame: Day 1
    • 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.
  • Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3
    • Time Frame: Day 1
    • 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.
  • Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4
    • Time Frame: Day 1
    • Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult
  • Time Required to Perform Each Step While Using the Caverject Impulse Delivery System
    • Time Frame: Day 1
    • Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.
  • Number of Participants Providing Comments to Any Question on the Participant Assessment Tool
    • Time Frame: Day 1
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

Age 40 to 70 Exclusion Criteria:

Prior syringe skills

Gender Eligibility: Male

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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