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

Needle Stick Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663635
• Other study ID #: 1550599
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2016
• Last updated: January 26, 2016
• Start date: January 2016
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Nemera La Verpilliere
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Needle Stick

Intervention

Device:
• Safe'N'Sound

Locations

Country	Name	City	State
United States	NAMSA	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Nemera La Verpilliere

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange		At time of testing, day 1	Yes
Secondary	Ease of Use		At time of testing, day 1	No
Secondary	Evaluator assessment of device handling		At time of testing, day 1	No
Secondary	Evaluator assessment of instructions		At time of testing, day 1	No
Secondary	Evaluator assessment of improvement of device over predecessor device		At time of testing, day 1	No