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

Nemera La Verpilliere30 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Needle Stick

Interventions

Safe'N'SoundDEVICE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

NAMSA

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange