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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 three hundred (300) Caucasian male and female Subjects was randomized (aged > 18 to < 65 years old) 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, 48 (forty eight) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HTL-STREFA S.A.safety lancet type 610 | Experimental |
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| HTL-STREFA S.A.safety lancet type 553-556 | Experimental |
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| HTL-STREFA S.A.safety lancet type 430 | Experimental |
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| HTL-STREFA S.A.safety lancet type 420 | Experimental |
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| HTL-STREFA S.A.safety lancet type 520 | Experimental |
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| HTL-STREFA S.A.safety lancet type 450 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acti-Lance Lite | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Volume (microliters) of blood in the capillary tube | The amount of capillary blood volume collected after a single lancing of the fingertip. | The blood volume was noted after 20 seconds |
| Volume (microliters) of blood in the capillary tube | The amount of capillary blood volume collected after a single lancing of the fingertip. | The blood volume was noted until the end of bleeding or up to 2 minutes time |
| Measure | Description | Time Frame |
|---|---|---|
| Pain perception | 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. | directly after lancing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioResearch Group Sp. z o.o. | Nadarzyn | Masovian Voivodeship | 05-830 | Poland |
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| Experimental |
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| HTL-STREFA S.A.safety lancet type 545-549 | Experimental |
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| Owem Mumford lancet | Experimental |
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| Medicore lancet | Experimental |
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| Arkray lancet | Experimental |
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| Medipurpose lancet | Experimental |
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| Sterilance lancet | Experimental |
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| Dynarex lancet | Experimental |
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| Ypsomed lancet | Experimental |
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| Promismed lancet | Experimental |
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| Cambridge Sensors lancet | Experimental |
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| Acti-Lance Universal | Device | 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. |
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| Acti-Lance Special | Device | 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. |
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| Medlance Plus Super Lite | Device | 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. |
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| Medlance Plus Lite | Device | 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. |
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| Medlance Plus Universal | Device | 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. |
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| Medlance Plus Extra | Device | 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. |
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| Medlance Plus Special | Device | 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. |
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| Prolance Micro Flow | Device | 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. |
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| Prolance Low Flow | Device | 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. |
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| Prolance Normal Flow | Device | 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. |
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| Prolance High Flow | Device | 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. |
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| Prolance Max Flow | Device | 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. |
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| Prolance Pediatric | Device | 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. |
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| Haemolance Micro Flow | Device | 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. |
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| Haemolance Low Flow | Device | 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. |
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| Haemolnace Normal Flow | Device | 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. |
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| Haemolance High Flow | Device | 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. |
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| Haemolance Max Flow | Device | 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. |
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| Haemolance Pediatric | Device | 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. |
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| MediSafe Solo 29 Gauge | Device | 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. |
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| MediSafe Solo 23 Gauge | Device | 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. |
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| ergoLance Micro Flow | Device | 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. |
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| ergoLance Normal Flow | Device | 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. |
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| ergoLance High Flow | Device | 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. |
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| Medlance (light blue) | Device | 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. |
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| Medlance (blue) | Device | 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. |
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| Medlance (dark blue) | Device | 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. |
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| Medlance (yellow) | Device | 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. |
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| Medlance (orange) | Device | 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. |
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| Medlance (red) | Device | 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. |
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| Unistik 3 Extra | Device | 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. |
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| Unistik 3 Comfort | Device | 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. |
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| Unistik Touch | Device | 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. |
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| ReadyLance (blue) | Device | 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. |
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| ReadyLance (orange) | Device | 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. |
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| AssureLance | Device | 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. |
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| AssureLance MicroFlow | Device | 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. |
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| Surgilance | Device | 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. |
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| Surgilance Lite (grey) | Device | 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. |
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| Surgilance Lite (purple) | Device | 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. |
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| SteriLance Lite2 | Device | 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. |
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| SensiLance (pink) | Device | 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. |
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| SteriLance Press | Device | 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. |
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| SensiLance (orange) | Device | 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. |
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| mylife | Device | 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. |
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| VeriFine | Device | 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. |
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| Microdot | Device | 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. |
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| Pain perception |
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. |
| after 30 minutes ± 5 min after lancing |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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