Needle Stick
Conditions
Brief summary
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
Detailed description
This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.
Interventions
DEVICESafe'N'Sound
Sponsors
Nemera La Verpilliere
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
The Evaluator must be: * Minimum of age 18 * Able to understand and provide signed consent for the study * Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires * Have no concerns about the ability to perform the simulated injections * With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)
Exclusion criteria
* If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange | At time of testing, day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Ease of Use | At time of testing, day 1 |
| Evaluator assessment of device handling | At time of testing, day 1 |
| Evaluator assessment of instructions | At time of testing, day 1 |
| Evaluator assessment of improvement of device over predecessor device | At time of testing, day 1 |
Countries
United States
Outcome results
None listed