Users Study Of The Caverject Delivery System

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

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

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

Conditions
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Healthy

Intervention / Treatment
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* Other: dual-chamber syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males Exclusion Criteria: Inability to read English; physical limitations preventing participant from operating the syringe

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

Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br> | Other: dual-chamber syringe<br>* dual-chamber syringe for mock injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivery System Success Rate (DSSR) | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Categorical Responses to the Participant Assessment Tool (PAT): 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 PAT: 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 PAT: Most Difficult Step? | 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. | Day 1 | 
| Number of Participants With Categorical Responses to the PAT: Syringe Easy to Use? | Participant responses were reported as follows: Very easy, Somewhat easy, Somewhat difficult, Very difficult. | Day 1 | 
| Number of Participants Providing Responses to Any Question on the PAT | 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? | Day 1 | 
| Time Required to Perform Segments 1 to 5 | 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). | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q1 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q2 | 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. | Day 1 | 
| Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q3 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q4 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q5 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q6 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q7 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q8 | 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. | Day 1 | 
| Number of Participants Whom the Observer Had Categorical Responses to in the OAT: Q9 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q10 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q11 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q12 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q13 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q14b | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q16 | 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. | Day 1 | 
| Number of Participants Which the Observer Had Categorical Responses to in the OAT: Q17 | 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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usability study