BioResearch Group Sp. z o.o.
Nadarzyn, Masovian Voivodeship, 05-830, Poland
Completed
NCT Number: NCT03752229
Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
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.
Completed
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Willing to sign the informed consent.
- Male and female volunteers
- Age between 18 and 65 inclusive
- Able to communicate well with the Investigator and comply with the requirements of the study
- Volunteers who are in good physical and mental health
Exclusion criteria
- Confirmed or suspected malignant cancer
- Pregnancy or breastfeeding (only for women with childbearing potential based on pregnancy test conducted at Site)
- History of poor blood circulation.
- Any skin condition on his or her fingers that prevents blood sampling
- Anxiety with needles or finger pricks
- Clotting disorders (including bleeding) in medical history
- Neuropathy or other condition affecting sensation in the hands.
- History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease)
- Currently participating in another study
- History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse
- Intake of alcohol within 48 hours prior to the start of the study (self-reporting)
- Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study
- Any other condition that in the Investigator opinion may negatively influence Subject's participation in the study
- Intake of medicines that affect blood coagulability (including anticoagulants such as vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin K antagonists).
Treatment and study plan
Acti-Lance Lite
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 610
Acti-Lance Universal
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 610
Acti-Lance Special
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 610
Medlance Plus Super Lite
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 553
Medlance Plus Lite
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 553
Medlance Plus Universal
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 554
Medlance Plus Extra
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 555
Medlance Plus Special
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 556
Prolance Micro Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 430
Prolance Low Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 430
Prolance Normal Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 430
Prolance High Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 430
Prolance Max Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 430
Prolance Pediatric
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 430
Haemolance Micro Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 420
Haemolance Low Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 420
Haemolnace Normal Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 420
Haemolance High Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 420
Haemolance Max Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 420
Haemolance Pediatric
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 420
MediSafe Solo 29 Gauge
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 520
MediSafe Solo 23 Gauge
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 520
ergoLance Micro Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 450
ergoLance Normal Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 450
ergoLance High Flow
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 450
Medlance (light blue)
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 545
Medlance (blue)
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 545
Medlance (dark blue)
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 546
Medlance (yellow)
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 547
Medlance (orange)
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 548
Medlance (red)
DeviceFinger 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.
Other names: HTL-STREFA S.A. safety lancet type 549
Unistik 3 Extra
DeviceFinger 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.
Other names: Owem Mumford lancet
Unistik 3 Comfort
DeviceFinger 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.
Other names: Owem Mumford lancet
Unistik Touch
DeviceFinger 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.
Other names: Owem Mumford lancet
ReadyLance (blue)
DeviceFinger 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.
Other names: Medicore lancet
ReadyLance (orange)
DeviceFinger 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.
Other names: Medicore lancet
AssureLance
DeviceFinger 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.
Other names: Arkray lancet
AssureLance MicroFlow
DeviceFinger 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.
Other names: Arkray lancet
Surgilance
DeviceFinger 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.
Other names: Medipurpose lancet
Surgilance Lite (grey)
DeviceFinger 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.
Other names: Medipurpose lancet
Surgilance Lite (purple)
DeviceFinger 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.
Other names: Medipurpose lancet
SteriLance Lite2
DeviceFinger 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.
Other names: Sterilance lancet
SensiLance (pink)
DeviceFinger 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.
Other names: Dynarex lancet
SteriLance Press
DeviceFinger 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.
Other names: Sterilance lancet
SensiLance (orange)
DeviceFinger 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.
Other names: Dynarex lancet
mylife
DeviceFinger 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.
Other names: Ypsomed lancet
VeriFine
DeviceFinger 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.
Other names: Promismed lancet
Microdot
DeviceFinger 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.
Other names: Cambridge Sensors lancet
Primary outcomes
-
Volume (microliters) of blood in the capillary tube
Time frame: The blood volume was noted after 20 seconds
The amount of capillary blood volume collected after a single lancing of the fingertip.
-
Volume (microliters) of blood in the capillary tube
Time frame: The blood volume was noted until the end of bleeding or up to 2 minutes time
The amount of capillary blood volume collected after a single lancing of the fingertip.
Secondary outcomes
-
Pain perception
Time frame: directly after lancing
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.
-
Pain perception
Time frame: after 30 minutes ± 5 min after lancing
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.
Sponsors and collaborators
Lead sponsor
HTL-Strefa S.A.
Industry
Registry information
Official study title
A Randomized, Single Blind, Uni-centre Study in Healthy Volunteers, to Determine Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2018
- First posted
- Nov 23, 2018
- Registry last updated
- Nov 26, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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