Needle StickNCT03807635
Simulated Clinical Use Testing on Safety Lancets (Test A)
A study testing ergoLance safety lancet and Acti-Lance safety lancet 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 HTL-Strefa's safety lancets 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?
- ergoLance safety lancet and Acti-Lance safety lancet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2018to 13 Dec 2018
- 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
- The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
- (HCP evaluators only) - evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
- evaluators will be United States (US) residents
- evaluators can read, write, and speak English
- evaluators are at least 18 years old
- evaluators are able to understand and provide signed consent for the study
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- evaluators are willing to comply with the study protocol, including being willing to answer questions and complete questionnaires.
- evaluators have no concerns about the ability to perform the simulated skin pricking.
- Lay person evaluators will have a diverse range of ages (18+ years), socioeconomic statuses, and race/ethnic backgrounds. UL-Wiklund will recruit some lay person evaluators with reduced vision and dexterity. Users without safety lancet experience may also be included in this simulated clinical use study.
Who cannot join
- HCPs:
- They do not routinely use safety lancets to collect capillary blood samples,
- They cannot read, write, and speak English,
- They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- They have participated in a product evaluation or marketing study involving safety lancets within the last six months
- Lay people:
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- They cannot read, write, and speak English,
- They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- They have participated in a product evaluation or marketing study involving safety lancets within the last six months
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Schlesinger Associates
Boston, Massachusetts, 02116
UL LLC
Chicago, Illinois, 60606
About this study
Official title: Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
A simulated clinical use testing on the HTL-Strefa's safety lancets
Read the detailed description
This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.
The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons.
- Conditions
- Needle Stick
- Being tested
- ergoLance safety lancet, Acti-Lance safety lancet
- Keywords
- needlestick, needlestick injury, safety lancet, sharps injury prevention, capillary blood sampling
- Medical subject headings
- Needlestick Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ergoLance safety lancetDevice
The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
Acti-Lance safety lancetDevice
The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.
| Study group | Role | What they receive |
|---|---|---|
| simulation of skin pricking type 450 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 450 Receives: Device: ergoLance safety lancet |
| simulation of skin pricking type 610 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 610 Receives: Device: Acti-Lance safety lancet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The true failure rate of the tested devices
Measured: At time of testing, up to 90 minutes
Effectiveness of the safety lancet's sharps injury prevention features
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
Measured: At time of testing, up to 90 minutes
Secondary outcomes (4)
Subjective assessments regarding evaluators' interactions with the tested safety lancets
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
Measured: At time of testing, up to 90 minutes
Safety of the devices based on the evaluators' assessments (five-point response scale)
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a "greater than" relationship.
Measured: At time of testing, up to 90 minutes
Various aspects of the ease of use.
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
Measured: At time of testing, up to 90 minutes
Any handling, usability questions / issues associated with the device
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
Measured: At time of testing, up to 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start30 Nov 2018
- Primary completion13 Dec 2018
- Study completion13 Dec 2018
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT03807635
- Sponsor's protocol ID
- Test A
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2019
- Last updated
- 22 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 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)
- ClinicalTrials.gov ID
- NCT03807635
- Acronym / sponsor ID
- Test A
- Conditions
- Needle Stick
- Keywords
- needlestick, needlestick injury, safety lancet, sharps injury prevention, capillary blood sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 13 Dec 2018 (actual)
- First posted
- 17 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 HTL-Strefa's safety lancets
Detailed description
This study aims to evaluate the safety of the use of the safety lancets: ergoLance and Acti-Lance in the prevention of NSI and to evaluate the user's opinion with regards to the handling characteristics of the medical devices.
The simulated use clinical study will involve healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples and lay persons.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simulation of skin pricking type 450 | Experimental | Device: ergoLance safety lancetThe evaluator simulated the capillary blood sampling with the safety lancet type 450 |
| simulation of skin pricking type 610 | Experimental | Device: Acti-Lance safety lancetThe evaluator simulated the capillary blood sampling with the safety lancet type 610 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
- (HCP evaluators only) - evaluators who routinely use safety lancets to collect capillary blood samples (prevention of the learning curve artifacts)
- evaluators will be United States (US) residents
- evaluators can read, write, and speak English
- evaluators are at least 18 years old
Key exclusion criteria (9 listed)
- They do not routinely use safety lancets to collect capillary blood samples,
- They cannot read, write, and speak English,
- They or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- They have participated in a product evaluation or marketing study involving safety lancets within the last six months
- They cannot read, write, and speak English,
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 |
|---|---|---|
| ergoLance safety lancetThe ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients. | Device | simulation of skin pricking type 450 |
| Acti-Lance safety lancetThe Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples. | Device | simulation of skin pricking type 610 |
Primary outcome
The true failure rate of the tested devices
Time frame: At time of testing, up to 90 minutes
Effectiveness of the safety lancet's sharps injury prevention features
Time frame: At time of testing, up to 90 minutes
Evaluator questionnaire using five-point response Likert scale (coded from 1 "strongly disagree" to 5 "strongly agree") to measure respondents' attitudes to a particular question or statement. Numbers assigned to Likert scale express a "greater than" relationship.
4 secondary outcomes
Subjective assessments regarding evaluators' interactions with the tested safety lancets
Time frame: At time of testing, up to 90 minutes
Safety of the devices based on the evaluators' assessments (five-point response scale)
Time frame: At time of testing, up to 90 minutes
Various aspects of the ease of use.
Time frame: At time of testing, up to 90 minutes
Any handling, usability questions / issues associated with the device
Time frame: At time of testing, up to 90 minutes
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 22 Jan 2019.
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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.
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 ergoLance safety lancet and Acti-Lance safety lancet 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 9 inclusion and 9 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 22 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 the tested devices (time frame: At time of testing, up to 90 minutes). The study lists 2 primary outcomes in all. 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 22 Jan 2019.