Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Study Overview
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Brief Summary
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A simulated clinical use testing on the DropSafe safety pen needle

Detailed Description
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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.

Official Title
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Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Conditions
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Needle Stick

Intervention / Treatment
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* Device: DropSafe safety pen needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simulation of injection<br>The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange. | Device: DropSafe safety pen needle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The true failure rate of DropSafe safety pen needle. | 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. | At time of testing, about an hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of use | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour | 
| Ability to follow the instructions for use | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour | 
| Ease of understanding the instructions for use | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour | 
| Problems associated with the device | Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree) | At time of testing, about an hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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needlestick, needlestick injury, pen needle, sharps injury prevention