Caverject User Study

Representative Users Study Of Operating Characteristics Of The Caverject Delivery System.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01008605

Enrollment

Registered

2009-11-06

Start date

2011-02-28

Completion date

2011-02-28

Last updated

2012-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction

Brief summary

The purpose of this study is to demonstrate the usability of the system.

Detailed description

demonstrate usability

Interventions

OTHERdelivery system

syringe

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

40 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Age 40 to 70

Exclusion criteria

Prior syringe skills

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System	Day 1	Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.

Secondary

Measure	Time frame	Description
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 2	Day 1	Participant Assessment Tool, Question 2: Instructions provided were clear? 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 Participant Assessment Tool: Question 3	Day 1	Participant Assessment Tool, Question 3: Most difficult step? Participant responses were reported as follows: No Steps Particularly Difficult, Attaching Needle, Mixing Solution, Getting The Air Out Of Syringe, Dialing Dose, Pushing Plunger, Other.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 1	Day 1	Participant Assessment Tool, Question 1: Instructions provided were useful? Participant responses were reported as follows: Very Useful, Somewhat Useful, Not Very Useful, Not Useful At All.
Time Required to Perform Each Step While Using the Caverject Impulse Delivery System	Day 1	Steps involved while using the Caverject Impulse Delivery System included assembly, mixing the dose, de-aeration, setting the dose, and injecting the dose.
Number of Participants Providing Comments to Any Question on the Participant Assessment Tool	Day 1	Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.
Number of Participants With Categorical Responses to the Participant Assessment Tool: Question 4	Day 1	Participant Assessment Tool, Question 4: Syringe easy to use? Participant responses were reported as follows: Very Easy, Somewhat Easy, Somewhat Difficult, Very Difficult

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Participants All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 \[PGE1\], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.	48
Total	48

Baseline characteristics

Characteristic	All Participants
Age Continuous	51.6 years STANDARD_DEVIATION 8.5
Age, Customized >= 65 years	6 participants
Age, Customized Between 18 and 44 years	11 participants
Age, Customized Between 45 and 64 years	31 participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	48 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 48
serious Total, serious adverse events	0 / 48

Outcome results

Primary

Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System

Percentage of participants who were able to successfully expel the selected dose from the Caverject Impulse Delivery System when relying on the modified Instructions for Use. The process was considered successful if the lower bound of the 95% confidence interval (CI) was more than (\>) 80% overall.

Time frame: Day 1

Population: Full Analysis Set (FAS): All eligible participants who read the instructions and attempted to deliver Alprostadil using the Caverject Impulse Delivery System. Each participant tested one device/dose combination.

Arm	Measure	Value (NUMBER)
All Participants	Percentage of Participants Who Successfully Operated the Caverject Impulse Delivery System	95.83 percentage of participants

Secondary

Number of Participants Providing Comments to Any Question on the Participant Assessment Tool

Number of participants providing comments on questions in the Participant Assessment Tool. Questions were as follows: were instructions clear, were instructions useful, which was the most difficult step, and was the syringe easy to use.

Time frame: Day 1