Needle StickPhase 3NCT02663635
Simulated Clinical Use Testing on Safe'N'Sound 1ML Stalked Passive Delivery System With Add-On Extended Finger Flanges
A Phase 3 study testing Safe'N'Sound in people with Needle Stick, run by Nemera La Verpilliere at 1 site in United States.
Trial summary
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges 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?
- Safe'N'Sound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2016
- Phase
- Phase 3
- 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
- The Evaluator must be:
- 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
- With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)
Who cannot join
- If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the reasons such as mental health.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges
A simulated clinical use testing the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
Read the detailed description
This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.
- Conditions
- Needle Stick
- Being tested
- Safe'N'Sound
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe'N'SoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Not described Receives: Device: Safe'N'Sound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange
Measured: At time of testing, day 1
Secondary outcomes (4)
Ease of Use
Measured: At time of testing, day 1
Evaluator assessment of device handling
Measured: At time of testing, day 1
Evaluator assessment of instructions
Measured: At time of testing, day 1
Evaluator assessment of improvement of device over predecessor device
Measured: At time of testing, day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionJan 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 3
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemera La Verpilliere
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Pratt, Principal investigator, NAMSA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663635
- Sponsor's protocol ID
- 1550599
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Clinical Use Testing on Safe'n'Sound 1mL Staked Passive Delivery System With add-on Extended Finger Flanges
- ClinicalTrials.gov ID
- NCT02663635
- Acronym / sponsor ID
- 1550599
- Conditions
- Needle Stick
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nemera La VerpilliereIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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 the Save'N'Sound 1mL staked Passive Delivery System with add-on extended finger flanges
Detailed description
This study aims to evaluate the safety of the use of the Safe'N'Sound 1mL staked passive delivery system cone version with add-on EFF in the prevention of needle stick injuries and to evaluate the user's satisfaction with regards to the handling characteristics of the product namely safety, design and the ease of use.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Safe'N'Sound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- With no financial interest in the sponsor (Nemera) or the CRO (NAMSA)
Key exclusion criteria (1 listed)
- If in the opinion of CRO, including the observer/monitor, the potential evaluator is not a good candidate for the study, including the 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 |
|---|---|---|
| Safe'N'Sound | Device | Single Arm |
Primary outcome
The true failure rate of the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange
Time frame: At time of testing, day 1
4 secondary outcomes
Ease of Use
Time frame: At time of testing, day 1
Evaluator assessment of device handling
Time frame: At time of testing, day 1
Evaluator assessment of instructions
Time frame: At time of testing, day 1
Evaluator assessment of improvement of device over predecessor device
Time frame: At time of testing, day 1
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 28 Jan 2016.
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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.
Timothy Pratt principal investigator
NAMSA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Safe'N'Sound in people with Needle Stick, run by Nemera La Verpilliere at 1 site 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 6 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 the Safe'n'Sound 1mL Staked Passive Delivery system with add-on extended finger flange (time frame: At time of testing, day 1). 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 28 Jan 2016.