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Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Primary Purpose

Needle Stick

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DropSafe safety pen needle
Sponsored by
HTL-Strefa S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Needle Stick focused on measuring needlestick, needlestick injury, pen needle, sharps injury prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NAMSA
  • NAMSA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

simulation of injection

Arm Description

The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.

Outcomes

Primary Outcome Measures

The true failure rate of DropSafe safety pen needle.
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.

Secondary Outcome Measures

Ease of use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Ability to follow the instructions for use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Ease of understanding the instructions for use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Problems associated with the device
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)

Full Information

First Posted
January 9, 2019
Last Updated
January 10, 2019
Sponsor
HTL-Strefa S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03803488
Brief Title
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
Official Title
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 28, 2016 (Actual)
Primary Completion Date
December 9, 2016 (Actual)
Study Completion Date
December 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HTL-Strefa S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A simulated clinical use testing on the DropSafe safety pen needle
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Needle Stick
Keywords
needlestick, needlestick injury, pen needle, sharps injury prevention

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
simulation of injection
Arm Type
Experimental
Arm Description
The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.
Intervention Type
Device
Intervention Name(s)
DropSafe safety pen needle
Primary Outcome Measure Information:
Title
The true failure rate of DropSafe safety pen needle.
Description
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.
Time Frame
At time of testing, about an hour
Secondary Outcome Measure Information:
Title
Ease of use
Description
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time Frame
At time of testing, about an hour
Title
Ability to follow the instructions for use
Description
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time Frame
At time of testing, about an hour
Title
Ease of understanding the instructions for use
Description
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time Frame
At time of testing, about an hour
Title
Problems associated with the device
Description
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time Frame
At time of testing, about an hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. 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.
Facility Information:
Facility Name
NAMSA
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
NAMSA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States

12. IPD Sharing Statement

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Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

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