An interventional study of DropSafe safety pen needle 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 2019-01-14.
Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other
A simulated clinical use testing on the DropSafe safety pen needle
This study aims to evaluate the safety of the use of DropSafe safety pen needle in the prevention of needle stick injuries (NSI) and to evaluate the user's satisfaction with regards to the handling characteristics of the product.
Exclusion Criteria:
The evaluator simulated the injection with the DropSafe safety pen needle and a pen injector with a sterile, water-filled cartridge using an orange.
Device: DropSafe safety pen needle
The true failure rate of DropSafe safety pen needle.
The failure rate of the safety feature for the DropSafe safety pen needle was estimated using the proportion of devices that fail out of the total tested. Failure was defined as NSI or contact with the needle after injection or non-complete activation of the safety feature.
Time frame: At time of testing, about an hour
Ease of use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time frame: At time of testing, about an hour
Ability to follow the instructions for use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time frame: At time of testing, about an hour
Ease of understanding the instructions for use
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time frame: At time of testing, about an hour
Problems associated with the device
Evaluator questionnaire using five-point response scale (strongly disagree - strongly agree)
Time frame: At time of testing, about an hour
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
HTL-Strefa S.A.