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A simulated clinical use testing on the HTL-Strefa's safety lancets
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simulation of skin pricking type 450 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 450 |
|
| simulation of skin pricking type 610 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 610 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ergoLance safety lancet | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
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:
Lay people:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UL LLC | Chicago | Illinois | 60606 | United States | ||
| Schlesinger Associates |
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| ID | Term |
|---|---|
| D016602 | Needlestick Injuries |
| ID | Term |
|---|---|
| D014951 | Wounds, Stab |
| D014950 | Wounds, Penetrating |
| D014947 | Wounds and Injuries |
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| Acti-Lance safety lancet | Device | 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. |
|
| 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 |
| Boston |
| Massachusetts |
| 02116 |
| United States |