Accident InjuryNCT04933461
Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test C)
A study testing Safety lancet in people with Accident Injury, run by HTL-Strefa S.A. at 2 sites in United States.
Trial summary
A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accident Injury
- What is being tested?
- 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
- 24 Sep 2019to 27 Sep 2019
- 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
- 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
- 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.
Who cannot join
- evaluators who do not routinely use safety lancets to collect capillary blood samples,
- evaluators who cannot read, write, and speak English,
- evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- evaluators who 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
Boston office
Boston, Massachusetts, 02116
Chicago office
Chicago, Illinois, 60606
About this study
A simulated clinical use testing to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.
Read the detailed description
This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.
The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
- Conditions
- Accident Injury
- Being tested
- Safety lancet
- Keywords
- safety lancet, capillary blood sampling, accidental needle-stick injury
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety lancetDevice
There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
| Study group | Role | What they receive |
|---|---|---|
| Simulation of skin pricking by using Medlance Plus | Other | Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries. Receives: Device: Safety lancet |
| Simulation of skin pricking by using myLance | Other | Estimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries. Receives: Device: 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 (3)
Evaluation of the safety of the devices based on the evaluators' assessments.
Measured: At time of testing, up to 90 minutes ]
Evaluation of various aspects of the ease of use.
Measured: At time of testing, up to 90 minutes ]
Detection of any handling, usability questions / issues associated with the device.
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 posted21 Jun 2021
- Study start24 Sep 2019
- Primary completion24 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accident InjuryStudies 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
- NCT04933461
- Sponsor's protocol ID
- Test C
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. 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 C)
- ClinicalTrials.gov ID
- NCT04933461
- Acronym / sponsor ID
- Test C
- Conditions
- Accident Injury
- Keywords
- safety lancet, capillary blood sampling, accidental needle-stick injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 21 Jun 2021 (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 to evaluate the Medlance Plus and myLance sharps injury prevention feature in accordance with the FDA's guidance on medical devices with sharps injury prevention features.
Detailed description
This study aims to evaluate the safety of the use of the following safety lancets: Medlance Plus and myLance in the prevention of needle-stick injury (NSI) and to evaluate the user's opinion with regard to the handling characteristics of the medical devices.
The simulated use clinical study involves healthcare professionals (HCPs) who routinely use safety lancets to collect blood samples.
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 by using Medlance Plus | Other | Device: Safety lancetEstimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries. |
| Simulation of skin pricking by using myLance | Other | Device: Safety lancetEstimation of the true failure rate of the device. Estimation of the sharps' injury prevention feature of the tested safety lancets are effective in preventing needle stick injuries. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- evaluators who do not routinely use safety lancets to collect capillary blood samples,
- evaluators who cannot read, write, and speak English,
- evaluators or a family member have a business or consulting relationship with a pharmaceutical or medical device company, or
- evaluators who have participated in a product evaluation or marketing study involving safety lancets within the last six months
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 |
|---|---|---|
| Safety lancetThere are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients. | Device | Simulation of skin pricking by using Medlance Plus, Simulation of skin pricking by using myLance |
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.
3 secondary outcomes
Evaluation of the safety of the devices based on the evaluators' assessments.
Time frame: At time of testing, up to 90 minutes ]
Evaluation of various aspects of the ease of use.
Time frame: At time of testing, up to 90 minutes ]
Detection of 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 21 Jun 2021.
- Individual participant dataSharing planned: No
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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 Safety lancet in people with Accident Injury, 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 7 inclusion and 4 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 21 Jun 2021. 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 21 Jun 2021.