Clinical Trial: Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges
Brief Summary: A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
Detailed Summary: 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.
Sponsor: Nemera La Verpilliere
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Ease of Use [ Time Frame: At time of testing, day 1 ]
- Evaluator assessment of device handling [ Time Frame: At time of testing, day 1 ]
- Evaluator assessment of instructions [ Time Frame: At time of testing, day 1 ]
- Evaluator assessment of improvement of device over predecessor device [ Time Frame: At time of testing, day 1 ]
Original Secondary Outcome: Same as current
Information By: Nemera La Verpilliere
Dates:
Date Received: January 7, 2016
Date Started: January 2016
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016
