An interventional study of ergoLance safety lancet and Acti-Lance 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: 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.
30 studies on the registry are indexed under Needlestick Injuries; 3 are open to participants now.
This study's enrollment of 20 is below the median of 67 across 23 interventional studies indexed under Needlestick Injuries.
Browse Needlestick Injuries studies →HTL-Strefa S.A. is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
The evaluator simulated the capillary blood sampling with the safety lancet type 450
Device: ergoLance safety lancet
The evaluator simulated the capillary blood sampling with the safety lancet type 610
Device: Acti-Lance safety lancet
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.
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
Ran from Nov 2018 to primary completion in Dec 2018, 0 months.
Of 12 interventional studies with no phase under Needlestick Injuries, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 0 and three quarters within 5. This study's 0 months is below that.
How these figures are worked out, and which studies are left out of them.
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.