An interventional study of Acti-Lance Lite and Acti-Lance Universal in Healthy, sponsored by HTL-Strefa S.A.. Completed at 1 site in Poland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by HTL-Strefa S.A. · Not applicable, Interventional, and Other
The study was a randomized, single blind, uni-center pivotal study in male and female healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets.
A group of one hundred (100) healthy Caucasian male and female Subjects (aged > 18 to \< 65 years old was randomized ) who were in good physical and mental condition. The Subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. Overall, 4 (four) different safety lancets were investigated per each Subject.
Overall, 16 (sixteen) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.
Exclusion Criteria:
Device: Acti-Lance Lite · Device: Acti-Lance Universal · Device: Acti-Lance Special
Device: Medlance Plus Super Lite · Device: Medlance Plus Lite · Device: Medlance Plus Universal · Device: Medlance Plus Extra · Device: Medlance Plus Special
Device: Prolance Micro Flow · Device: Prolance Low Flow · Device: Prolance Normal Flow · Device: Prolance High Flow · Device: Prolance Max Flow · Device: Prolance Pediatric
Device: MediSafe Solo 29 Gauge · Device: MediSafe Solo 23 Gauge
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 610
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 610
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 610
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 430
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 430
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 430
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 430
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 430
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 430
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 520
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol. Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Also known as: HTL-STREFA S.A.safety lancet type 520
Volume (microliters) of blood in the capillary tube
The amount of capillary blood volume collected after a single lancing of the fingertip.
Time frame: The blood from the puncture site was collected to the capillaries by pressing during 2 minutes
Pain perception: VAS
The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.
Time frame: 5 minutes after lancing
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HTL-Strefa S.A.