Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03803488

Enrollment

Registered

2019-01-14

Start date

2016-09-28

Completion date

2016-12-09

Last updated

2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Needle Stick

Keywords

needlestick, needlestick injury, pen needle, sharps injury prevention

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.

Interventions

DEVICEDropSafe safety pen needle

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
The true failure rate of DropSafe safety pen needle.	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.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026