Needle StickNCT03803488
Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
A study testing DropSafe safety pen needle in people with Needle Stick, run by HTL-Strefa S.A. at 2 sites in United States.
Trial summary
A simulated clinical use testing on the DropSafe safety pen needle Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Needle Stick
- What is being tested?
- DropSafe safety pen needle
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Sep 2016to 9 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NAMSA
Golden Valley, Minnesota, 55422
NAMSA
Minneapolis, Minnesota, 55426
About this study
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
- Needle Stick
- Being tested
- DropSafe safety pen needle
- Keywords
- needlestick, needlestick injury, pen needle, sharps injury prevention
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DropSafe safety pen needleDevice
| Study group | Role | What they receive |
|---|---|---|
| simulation of injection | Experimental | The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange. Receives: Device: DropSafe safety pen needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of testing, about an hour
Secondary outcomes (4)
Ease of use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Measured: 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)
Measured: 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)
Measured: At time of testing, about an hour
Problems associated with the device
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Measured: At time of testing, about an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start28 Sep 2016
- Primary completion9 Dec 2016
- Study completion9 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Needle StickStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- HTL-Strefa S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803488
- Sponsor's protocol ID
- CIP v1.0 29JAN2016
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 14 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Clinical Use Testing on the DropSafe Safety Pen Needle
- ClinicalTrials.gov ID
- NCT03803488
- Acronym / sponsor ID
- CIP v1.0 29JAN2016
- Conditions
- Needle Stick
- Keywords
- needlestick, needlestick injury, pen needle, sharps injury prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2016 (actual)
- Primary completion
- 9 Dec 2016 (actual)
- Study completion
- 9 Dec 2016 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| simulation of injection | Experimental | Device: DropSafe safety pen needleThe evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DropSafe safety pen needle | Device | simulation of injection |
Primary outcome
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.
4 secondary outcomes
Ease of use
Time frame: At time of testing, about an hour
Ability to follow the instructions for use
Time frame: At time of testing, about an hour
Ease of understanding the instructions for use
Time frame: At time of testing, about an hour
Problems associated with the device
Time frame: At time of testing, about an hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2019.
Related trials for Needle Stick
Active, not recruitingObservational study
Determination of NSI Regarding Bloodborne Pathogens Among Healthcare Workers at Tertiary Care, DIK
Needle Stick Injuries
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DropSafe safety pen needle in people with Needle Stick, run by HTL-Strefa S.A. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The true failure rate of DropSafe safety pen needle. (time frame: At time of testing, about an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019; AzTrials last refreshed its copy on 26 Oct 2026.