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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: Haemolance Plus, Prolance and MediSafe Solo 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simulation of skin pricking type 420 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 420 |
|
| simulation of skin pricking type 430 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 430 |
|
| simulation of skin pricking type 520 | Experimental | The evaluator simulated the capillary blood sampling with the safety lancet type 520 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Haemolance Plus safety lancet | Device | Haemolance Plus safety lancet type 420 is a sterile, single use medical device 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:
Exclusion Criteria:
Individuals will be excluded if:
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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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| Prolance safety lancet | Device | Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients. |
|
| MediSafe Solo safety lancet | Device | MediSafe Solo safety lancet type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients. |
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| 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 |