Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

January 10, 2019 updated by: HTL-Strefa S.A.
A simulated clinical use testing on the DropSafe safety pen needle

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

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
      • Golden Valley, Minnesota, United States, 55422
        • NAMSA
      • Minneapolis, Minnesota, United States, 55426
        • 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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Minimum of age 18.
  2. Able to understand and provide signed consent for the study.
  3. Willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
  4. Have no concerns about the ability to perform the simulated injections.
  5. Have no financial interest in the sponsor (HTL-Strefa S.A.) or the MRO (NAMSA).

Exclusion Criteria:

1. If in the opinion of the sponsor or MRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including for 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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: simulation of injection
The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.
Device: DropSafe safety pen needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The true failure rate of DropSafe safety pen needle.
Time Frame: At time of testing, about an hour
The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.
At time of testing, about an hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of use
Time Frame: At time of testing, about an hour
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
At time of testing, about an hour
Ability to follow the instructions for use
Time Frame: At time of testing, about an hour
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
At time of testing, about an hour
Ease of understanding the instructions for use
Time Frame: At time of testing, about an hour
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
At time of testing, about an hour
Problems associated with the device
Time Frame: At time of testing, about an hour
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
At time of testing, about an hour

Collaborators and Investigators

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

Sponsor

HTL-Strefa S.A.

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 (Actual)

September 28, 2016

Primary Completion (Actual)

December 9, 2016

Study Completion (Actual)

December 9, 2016

Study Registration Dates

First Submitted

January 9, 2019

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 14, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP v1.0 29JAN2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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