An interventional study of Haemolance Plus safety lancet and Prolance safety lancet in Needle Stick, sponsored by HTL-Strefa S.A.. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-22.
Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other
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.
The inclusion criteria for HCP and lay person evaluators have been chosen based on FDA guidance:
Exclusion Criteria:
Individuals will be excluded if:
The evaluator simulated the capillary blood sampling with the safety lancet type 420
Device: Haemolance Plus safety lancet
The evaluator simulated the capillary blood sampling with the safety lancet type 430
Device: Prolance safety lancet
The evaluator simulated the capillary blood sampling with the safety lancet type 520
Device: MediSafe Solo safety lancet
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
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 type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
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
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
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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HTL-Strefa S.A.