Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01747928 | Users Study Of The Caverject Delivery System | EARLY_PHASE1 | COMPLETED | 48 | — | — | Mar 1, 2013 | Mar 1, 2013 | May 2, 2014 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| dual-chamber syringe | OTHER | dual-chamber syringe for mock injection |
Inclusion Criteria: * Healthy males Exclusion Criteria: * Inability to read English; * physical limitations preventing participant from operating the syringe