Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges

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

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-01-31

Brief Summary

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A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges

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Detailed Description

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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.

Conditions

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Needle Stick

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type OTHER

Safe'N'Sound

Intervention Type DEVICE

Interventions

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Safe'N'Sound

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes