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

Phase 3

Completed

• Conditions: Needle Stick
• Interventions: Device: Safe'N'Sound

• Registration Number: NCT02663635
• Lead Sponsor: Nemera La Verpilliere

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2016-01
• Study Start: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Safe'N'Sound	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Evaluator assessment of device handling	At time of testing, day 1
Ease of Use	At time of testing, day 1
Evaluator assessment of instructions	At time of testing, day 1
Evaluator assessment of improvement of device over predecessor device	At time of testing, day 1

Trial Locations

Locations (1)

NAMSA; 🇺🇸 Minneapolis, Minnesota, United States