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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Accident Injury

Intervention / Treatment
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* Device: Safety lancet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

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 |
| --- | --- |
| Other: Simulation of skin pricking by using Medlance Plus<br>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. | Device: Safety lancet<br>* There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.<br>|
| Other: Simulation of skin pricking by using myLance<br>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. | Device: Safety lancet<br>* There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.<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 |
| --- | --- | --- |
| Evaluation of the safety of the devices based on the evaluators' assessments. |  | At time of testing, up to 90 minutes ] | 
| Evaluation of various aspects of the ease of use. |  | At time of testing, up to 90 minutes ] | 
| Detection of any handling, usability questions / issues associated with the device. |  | 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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safety lancet, capillary blood sampling, accidental needle-stick injury