Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-28

Study Completion Date

2016-12-09

Brief Summary

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A simulated clinical use testing on the DropSafe safety pen needle

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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.

Conditions

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Needle Stick

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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simulation of injection

The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.

Group Type EXPERIMENTAL

DropSafe safety pen needle

Intervention Type DEVICE

Interventions

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DropSafe safety pen needle

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes