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

Nemera

Status and phase: Completed; Phase 3

Conditions: Needle Stick

Treatments: Device: Safe'N'Sound

Study type: Interventional

Funder types: Industry

Identifiers

NCT02663635

1550599

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Single Arm

Other group

Treatment:

Device: Safe'N'Sound