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

January 26, 2016 updated by: Nemera La Verpilliere

Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55422
        • NAMSA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
Device: Safe'N'Sound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At time of testing, day 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Ease of Use
Time Frame: At time of testing, day 1
At time of testing, day 1
Evaluator assessment of device handling
Time Frame: At time of testing, day 1
At time of testing, day 1
Evaluator assessment of instructions
Time Frame: At time of testing, day 1
At time of testing, day 1
Evaluator assessment of improvement of device over predecessor device
Time Frame: At time of testing, day 1
At time of testing, day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemera La Verpilliere

Investigators

  • Principal Investigator: Timothy Pratt, NAMSA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

January 7, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Estimate)

January 28, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1550599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Needle Stick

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe