Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
- 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: Haemolance Micro Flow
- Device: Haemolance Low Flow
- Device: Haemolnace Normal Flow
- Device: Haemolance High Flow
- Device: Haemolance Max Flow
- Device: Haemolance Pediatric
- Device: MediSafe Solo 29 Gauge
- Device: MediSafe Solo 23 Gauge
- Device: ergoLance Micro Flow
- Device: ergoLance Normal Flow
- Device: ergoLance High Flow
- Device: Medlance (light blue)
- Device: Medlance (blue)
- Device: Medlance (dark blue)
- Device: Medlance (yellow)
- Device: Medlance (orange)
- Device: Medlance (red)
- Device: Unistik 3 Extra
- Device: Unistik 3 Comfort
- Device: Unistik Touch
- Device: ReadyLance (blue)
- Device: ReadyLance (orange)
- Device: AssureLance
- Device: AssureLance MicroFlow
- Device: Surgilance
- Device: Surgilance Lite (grey)
- Device: Surgilance Lite (purple)
- Device: SteriLance Lite2
- Device: SteriLance Press
- Device: SensiLance (pink)
- Device: SensiLance (orange)
- Device: mylife
- Device: VeriFine
- Device: Microdot
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Mazowieckie
-
Nadarzyn, Mazowieckie, Poland, 05-830
- BioResearch Group sp. z o.o.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: 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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: 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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: HTL-STREFA S.A.safety lancet type 420
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: 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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: HTL-STREFA S.A.safety lancet type 450
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: HTL-STREFA S.A.safety lancet type 545-549
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Owem Mumford lancet
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Medicore lancet
|
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Arkray lancet
|
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Medipurpose lancet
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Sterilance lancet
|
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Dynarex lancet
|
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.
Other Names:
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.
Other Names:
|
|
EXPERIMENTAL: Ypsomed lancet
|
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.
Other Names:
|
|
EXPERIMENTAL: Promismed lancet
|
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.
Other Names:
|
|
EXPERIMENTAL: Cambridge Sensors lancet
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
The blood volume was noted after 20 seconds
|
|
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.
|
The blood volume was noted until the end of bleeding or up to 2 minutes time
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
directly after lancing
|
|
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.
|
after 30 minutes ± 5 min after lancing
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Anticonvulsants
- Neuromuscular Agents
- Muscle Relaxants, Central
- Diazepam
Other Study ID Numbers
- 02LAN2017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Acti-Lance Lite
-
HTL-Strefa S.A.Completed
-
HTL-Strefa S.A.Completed
-
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, France; Sport Health Center of Auvergne-Rhône Alpes; INSERM... and other collaboratorsRecruiting
-
MIS Implant Technologies, LtdRambam Health Care CampusNot yet recruiting
-
T.C. ORDU ÜNİVERSİTESİCompleted
-
The Miriam HospitalNational Institutes of Health (NIH); National Center for Complementary and...CompletedSecondary Prevention of Coronary Heart DiseaseUnited States
-
Hektoen Institute for Medical ResearchNational Institutes of Health (NIH)RecruitingHIV Infections | Sexual BehaviorUnited States
-
Centre Hospitalier Universitaire de NīmesCompleted
-
Massachusetts General HospitalCompleted