Status:
COMPLETED
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
Lead Sponsor:
HTL-Strefa S.A.
Conditions:
Needle Stick
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A simulated clinical use testing on the DropSafe safety pen needle
Detailed Description
This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling ch...
Eligibility Criteria
Inclusion
- 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.
- Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).
Exclusion
- 1\. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for reasons such as mental health.
Key Trial Info
Start Date :
September 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 9 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03803488
Start Date
September 28 2016
End Date
December 9 2016
Last Update
January 14 2019
Active Locations (2)
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1
NAMSA
Golden Valley, Minnesota, United States, 55422
2
NAMSA
Minneapolis, Minnesota, United States, 55426