An interventional study of Safety lancet in Accident Injury, 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 2021-06-21.
Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other
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.
128 studies on the registry are indexed under Accidental Injuries; 39 are open to participants now.
This study's enrollment of 20 is below the median of 110 across 67 interventional studies indexed under Accidental Injuries.
Browse Accidental 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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Exclusion Criteria:
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.
Device: Safety lancet
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.
Device: Safety lancet
There are sterile, single-use safety lancets 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
Evaluation of the safety of the devices based on the evaluators' assessments.
Time frame: At time of testing, up to 90 minutes ]
Evaluation of various aspects of the ease of use.
Time frame: At time of testing, up to 90 minutes ]
Detection of any handling, usability questions / issues associated with the device.
Time frame: At time of testing, up to 90 minutes ]
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Sep 2019, 0 months.
Of 35 interventional studies with no phase under Accidental Injuries, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 41. 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 Jun 2021. You cannot join it, but the record below documents what was studied.
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HTL-Strefa S.A.