Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

NCT03803488 — Not applicable, Completed, 35 participants, HTL-Strefa S.A.

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Registry	NCT03803488
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	35 (Actual)
Sponsor	HTL-Strefa S.A. (Industry)
Conditions	Needle Stick
Interventions	DropSafe safety pen needle (Device)
Dates	start 2016-09-28, primary completion 2016-12-09, completion 2016-12-09, first posted 2019-01-14, last updated 2019-01-14
Locations	2 sites in United States

-Summary

A simulated clinical use testing on the DropSafe safety pen needle

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+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 characteristics of the product.

+Arms and interventions

Arm	Type	Interventions	Description
simulation of injection	Experimental	Device: DropSafe safety pen needle	The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.

DropSafe safety pen needle (Device)

+Outcome measures

Primary outcomes

The true failure rate of DropSafe safety pen needle. [At time of testing, about an hour]: The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.

Secondary outcomes

Ease of use [At time of testing, about an hour]: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Ability to follow the instructions for use [At time of testing, about an hour]: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Ease of understanding the instructions for use [At time of testing, about an hour]: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Problems associated with the device [At time of testing, about an hour]: Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

1. Minimum of age 18.
2. Able to understand and provide signed consent for the study.
3. Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
4. Have no concerns about the ability to perform the simulated injections.
5. Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).

Exclusion Criteria:

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.

+Locations (2)

Facility	City	Country	Status
NAMSA	Golden Valley, Minnesota	United States
NAMSA	Minneapolis, Minnesota	United States

My Notes

Public

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