Users Study Of The Caverject Delivery System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01747928
First received: November 20, 2012
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use.


Condition Intervention Phase
Healthy
Other: dual-chamber syringe
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Representative Users Study Of The Operating Characteristics Of The Caverject Delivery System

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Delivery System Success Rate (DSSR) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): Instructions Provided Were Useful? [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 PAT: Instructions Provided Were Clear? [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 PAT: Most Difficult Step? [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Participant responses were reported as follows: No steps really difficult, Attaching needle, Mixing the solution, Getting the air out of syringe, Setting the dose, Pushing plunger, Other.

  • Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult.

  • Number of Participants Providing Responses to Any Question on the PAT [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Number of participants providing responses on questions in the PAT. Questions were as follows: What step did you stop? Why?; Instructions provided were useful?; Instructions provided were clear?; Most difficult step?; Syringe easy to use?

  • Time Required to Perform Segments 1 to 5 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Steps involved while using the Caverject Impulse Delivery System were categorized into segments: Segment 1 (Assembly While Using the Caverject Impulse Delivery System), Segment 2 (Mixing the Solution), Segment 3 (De-aerating the Syring While Using the Caverject Impulse Delivery System), Segment 4 (Setting the Dose) and Segment 5 (Performing the Injection While Using the Caverject Impulse Delivery System).

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q1: Participant assembled the components correctly. Observer responses were reported as follows: Yes, No. A "No" answer indicated failure according to the OAT. Q1 and Q2 made up Segment 1: Assembly of Components.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q2: Evidence of mechanical malfunction or defect for Segment 1. Observer responses were reported as follows: Yes, No. Q1 and Q2 made up Segment 1: Assembly of Components.

  • Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q3: Participant performed mixing step correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q3 to Q5 made up Segment 2: Mixing the Solution.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q4: Participant positioned piston correctly. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q3 to Q5 made up Segment 2: Mixing the Solution.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q5: Evidence of mechanical malfunction/defect for Segment 2. Observer responses were reported as follows: Yes, No. Q3 to Q5 made up Segment 2: Mixing the Solution.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q6: De-aeration step performed successfully. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q7: Participant depressed the plunger correctly to de-aerate the syringe. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the SAP. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q8: Evidence of mechanical malfunction/defect for Segment 3. Observer responses were reported as follows: Yes, No. Q6 to Q8 made up Segment 3: De-aeration of the Syringe.

  • Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q9: Participant was able to set a dose (any dose) for delivery. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q9 and Q10 made up Segment 4: Setting the Dose.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q10: Evidence of mechanical malfunction/defect for Segment 4. Observer responses were reported as follows: Yes, No. Q9 and Q10 made up Segment 4: Setting the Dose.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q11: Participant successfully set the correct dose (as assigned). Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q12: Participant successfully expelled the dose into the target. Observer responses were reported as follows: Yes, No. A "No" response indicated failure according to the OAT. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q13: Was there any difficulty/obstruction encountered in expelling dose? Observer responses were reported as follows: Yes, No. A "Yes" response indicated failure according to the SAP. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q14b: Participant successfully expelled/injected the assigned dose (per Dose Card). Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q16: Evidence of mechanical malfunction/defect. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.

  • Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    OAT, Q17: Participant understood reason excess liquid was present after a partial-dose injection. Observer responses were reported as follows: Yes, No. Q11 to Q17 made up Segment 5: Performing the Simulated Injection.


Enrollment: 48
Study Start Date: March 2013
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 Other: dual-chamber syringe
dual-chamber syringe for mock injection

Detailed Description:

Usability testing of the dual-chambered syringe in conjunction with the proposed patient instructions for use

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males

Exclusion Criteria:

  • Inability to read English;
  • physical limitations preventing participant from operating the syringe
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01747928

Locations
United States, Kansas
Vince and Associates Clinical Research
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01747928     History of Changes
Other Study ID Numbers: A6711036
Study First Received: November 20, 2012
Results First Received: April 1, 2014
Last Updated: April 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
usability study

Additional relevant MeSH terms:
Alprostadil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Urological Agents

ClinicalTrials.gov processed this record on August 25, 2014