Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
dual-chamber syringe · 1 trial · 1 indication
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
The dual-chamber syringe is an investigational medical device being studied for use in healthy individuals. It is currently in Phase 1 clinical development, with one completed early Phase 1 trial. The device is being developed by Pfizer, Inc. (NYSE: PFE).
The dual-chamber syringe is being studied for use in healthy individuals. The completed clinical trial was a user study of the Caverject Delivery System, which is the device being evaluated. The study enrolled 48 healthy male participants aged 40 years and older in the United States.
The dual-chamber syringe is being developed by Pfizer, Inc. (NYSE: PFE). The company conducted a completed early Phase 1 user study of the Caverject Delivery System, which is the device being evaluated. The trial enrolled 48 healthy male participants in the United States.
The dual-chamber syringe is in Phase 1 clinical development. The completed trial, NCT01747928, was an early Phase 1 user study of the Caverject Delivery System. The study enrolled 48 healthy male participants and was conducted in the United States.
The dual-chamber syringe has one completed clinical trial, NCT01747928, titled 'Users Study Of The Caverject Delivery System'. This early Phase 1 study enrolled 48 healthy male participants aged 40 years and older in the United States. The trial was uncontrolled and not randomized or double-blinded.
Yes, the dual-chamber syringe is the same as the Caverject Delivery System. The completed clinical trial, NCT01747928, was a user study of the Caverject Delivery System, which is the device being evaluated. The study enrolled 48 healthy male participants in the United States.