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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
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.
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.
UL LLC
Chicago, Illinois, United States
Schlesinger Associates
Boston, Massachusetts, United States
The true failure rate of the tested devices
Time frame: 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.
Time frame: At time of testing, up to 90 minutes
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.
Time frame: 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.
Time frame: 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.
Time frame: At time of testing, up to 90 minutes
Any handling, usability questions / issues associated with the device
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: At time of testing, up to 90 minutes