Simulated Clinical Use Testing on Safety Lancets (Test A)

Study Overview
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Brief Summary
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A simulated clinical use testing on the HTL-Strefa's safety lancets

Detailed Description
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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.

Official Title
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Simulated Clinical Use Testing to Evaluate Sharps Injury Prevention Features of HTL-STREFA's Safety Lancets (Test A)

Conditions
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Needle Stick

Intervention / Treatment
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* Device: ergoLance safety lancet
* Device: Acti-Lance safety lancet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simulation of skin pricking type 450<br>The evaluator simulated the capillary blood sampling with the safety lancet type 450 | Device: ergoLance safety lancet<br>* 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.<br>|
| Experimental: simulation of skin pricking type 610<br>The evaluator simulated the capillary blood sampling with the safety lancet type 610 | Device: Acti-Lance safety lancet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | At time of testing, up to 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | At time of testing, up to 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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needlestick, needlestick injury, safety lancet, sharps injury prevention, capillary blood sampling