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
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
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.
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
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
Learn more about this trial
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
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