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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Simulation of skin pricking by using Medlance Plus | Other | 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. |
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| Simulation of skin pricking by using myLance | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Safety lancet | Device | There 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 |
|---|---|---|
| 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 ] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago office | Chicago | Illinois | 60606 | United States | ||
| Boston office |
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| ID | Term |
|---|---|
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Detection of any handling, usability questions / issues associated with the device. | At time of testing, up to 90 minutes ] |
| Boston |
| Massachusetts |
| 02116 |
| United States |