CompletedNCT03803488Updated Jan 14, 2019

Simulated Clinical Use Testing on the DropSafe Safety Pen Needle

An interventional study of DropSafe safety pen needle in Needle Stick, sponsored by HTL-Strefa S.A.. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-14.

Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other

From the registry’s dates

Registered 2 years 3 months after the study started (first participant enrolled Sep 2016, registered Jan 2019).

Phase: Not applicable
Study type: Interventional
Enrollment: 35
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

A simulated clinical use testing on the DropSafe safety pen needle

Read the 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.

Conditions studied

Needle Stick

Browse trials for

Needlestick Injuries 30

Keywords

needlestick
needlestick injury
pen needle
sharps injury prevention

In context

Needlestick Injuries

30 studies on the registry are indexed under Needlestick Injuries; 3 are open to participants now.

This study's enrollment of 35 is below the median of 67 across 23 interventional studies indexed under Needlestick Injuries.

Browse Needlestick Injuries studies →

Lead sponsor

HTL-Strefa S.A. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

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

Interventions

DeviceDropSafe safety pen needle

What researchers measure

Primary outcomes

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.
Time frame: At time of testing, about an hour

Secondary outcomes

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

Study locations

2 sites

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

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2016 to primary completion in Dec 2016, 2 months.

Of 12 interventional studies with no phase under Needlestick Injuries, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 0 and three quarters within 5. This study's 2 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 9, 2019
First posted: Jan 14, 2019
StartActual: Sep 28, 2016
Primary completionActual: Dec 9, 2016
CompletionActual: Dec 9, 2016
Last update: Jan 14, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03803488
Lead sponsor: HTL-Strefa S.A.
Responsible party: Sponsor
First posted: Jan 14, 2019
Start date: Sep 28, 2016
Primary completion: Dec 9, 2016
Completion: Dec 9, 2016
Last update: Jan 14, 2019

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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