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Completed

NCT Number: NCT02663635

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

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

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Key information

Conditions

Needle Stick Needlestick Injuries Wounds and Injuries Wounds, Penetrating Wounds, Stab

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NAMSA

Minneapolis, Minnesota, 55422, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Safe'N'Sound

Device

Primary outcomes

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

    Time frame: At time of testing, day 1

Secondary outcomes

  1. Ease of Use

    Time frame: At time of testing, day 1

  2. Evaluator assessment of device handling

    Time frame: At time of testing, day 1

  3. Evaluator assessment of instructions

    Time frame: At time of testing, day 1

  4. Evaluator assessment of improvement of device over predecessor device

    Time frame: At time of testing, day 1

Sponsors and collaborators

Lead sponsor

Nemera La Verpilliere

Industry

Registry information

Official study title

Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2016
Registry last updated
Jan 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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