Needle Stick
Conditions
Keywords
needlestick, needlestick injury, safety lancet, sharps injury prevention, capillary blood sampling
Brief summary
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.
Interventions
DEVICEergoLance safety lancet
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.
DEVICEActi-Lance safety lancet
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.
Sponsors
HTL-Strefa S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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 * 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.
Exclusion criteria
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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The true failure rate of the tested devices | At time of testing, up to 90 minutes | — |
| Effectiveness of the safety lancet's sharps injury prevention features | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the devices based on the evaluators' assessments (five-point response scale) | 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 any and all observed needlestick injuries and device malfunctions. Numbers assigned to Likert scale express a greater than relationship. |
| Subjective assessments regarding evaluators' interactions with the tested safety lancets | 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. |
| Various aspects of the ease of use. | 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. |
| Any handling, usability questions / issues associated with the device | 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. |
Countries
United States
Outcome results
None listed