Phase 3
Completed N=48
Caverject User Study
Source: ClinicalTrials.gov NCT01008605 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System — 95.83 percentage of participants
Summary
The purpose of this study is to demonstrate the usability of the system.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System |
95.83 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1 |
44; 4; 0; 0 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2 |
43; 4; 1; 0 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 3 |
38; 2; 1; 0; 2; 4 | — |
| SECONDARY Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4 |
43; 4; 1; 0 | — |
| SECONDARY Time Required to Perform Each Step While Using the Caverject Impulse Delivery System |
103.2; 141.7; 119.2; 115.4; 127.5; 110.2 | — |
| SECONDARY Number of Participants Providing Comments to Any Question on the Participant Assessment Tool |
1; 0; 0; 0; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
Age 40 to 70
Exclusion Criteria
Prior syringe skills
Data sourced from ClinicalTrials.gov (NCT01008605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.