HealthyNCT03752229
Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
A study testing Acti-Lance Lite, Acti-Lance Universal and Acti-Lance Special in people with Healthy, run by HTL-Strefa S.A. at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acti-Lance Lite, Acti-Lance Universal and Acti-Lance Special
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePoland
- Study dates
- 8 Dec 2017to 30 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
Poland1 site
BioResearch Group Sp. z o.o.
Nadarzyn, Masovian Voivodeship, 05-830
About this study
Official 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
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.
- Conditions
- Healthy
- Being tested
- Acti-Lance Lite, Acti-Lance Universal, Acti-Lance Special, Medlance Plus Super Lite, Medlance Plus Lite
- Keywords
- safety lancets, lancet, capillary blood, capillary blood sampling, blood volume, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acti-Lance LiteDevice
Also called 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.
Acti-Lance UniversalDevice
Also called 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.
Acti-Lance SpecialDevice
Also called 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.
Medlance Plus Super LiteDevice
Also called HTL-STREFA S.A. safety lancet type 553
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.
Medlance Plus LiteDevice
Also called HTL-STREFA S.A. safety lancet type 553
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.
Medlance Plus UniversalDevice
Also called HTL-STREFA S.A. safety lancet type 554
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.
Medlance Plus ExtraDevice
Also called HTL-STREFA S.A. safety lancet type 555
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.
Medlance Plus SpecialDevice
Also called HTL-STREFA S.A. safety lancet type 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.
Prolance Micro FlowDevice
Also called 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.
Prolance Low FlowDevice
Also called 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.
Prolance Normal FlowDevice
Also called 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.
Prolance High FlowDevice
Also called 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.
Prolance Max FlowDevice
Also called 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.
Prolance PediatricDevice
Also called 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.
Haemolance Micro FlowDevice
Also called 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.
Haemolance Low FlowDevice
Also called 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.
Haemolnace Normal FlowDevice
Also called 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.
Haemolance High FlowDevice
Also called 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.
Haemolance Max FlowDevice
Also called 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.
Haemolance PediatricDevice
Also called 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.
MediSafe Solo 29 GaugeDevice
Also called 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.
MediSafe Solo 23 GaugeDevice
Also called 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.
ergoLance Micro FlowDevice
Also called 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.
ergoLance Normal FlowDevice
Also called 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.
ergoLance High FlowDevice
Also called 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.
Medlance (light blue)Device
Also called HTL-STREFA S.A. safety lancet type 545
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.
Medlance (blue)Device
Also called HTL-STREFA S.A. safety lancet type 545
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.
Medlance (dark blue)Device
Also called HTL-STREFA S.A. safety lancet type 546
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.
Medlance (yellow)Device
Also called HTL-STREFA S.A. safety lancet type 547
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.
Medlance (orange)Device
Also called HTL-STREFA S.A. safety lancet type 548
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.
Medlance (red)Device
Also called HTL-STREFA S.A. safety lancet type 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.
Unistik 3 ExtraDevice
Also called 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.
Unistik 3 ComfortDevice
Also called 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.
Unistik TouchDevice
Also called 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.
ReadyLance (blue)Device
Also called 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.
ReadyLance (orange)Device
Also called 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.
AssureLanceDevice
Also called 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.
AssureLance MicroFlowDevice
Also called 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.
SurgilanceDevice
Also called 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.
Surgilance Lite (grey)Device
Also called 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.
Surgilance Lite (purple)Device
Also called 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.
SteriLance Lite2Device
Also called 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.
SensiLance (pink)Device
Also called 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.
SteriLance PressDevice
Also called 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.
SensiLance (orange)Device
Also called 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.
mylifeDevice
Also called 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.
VeriFineDevice
Also called 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.
MicrodotDevice
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| HTL-STREFA S.A.safety lancet type 610 | Experimental | Not described Receives: Device: Acti-Lance Lite; Device: Acti-Lance Universal; Device: Acti-Lance Special |
| HTL-STREFA S.A.safety lancet type 553-556 | Experimental | Not described Receives: Device: Medlance Plus Super Lite; Device: Medlance Plus Lite; Device: Medlance Plus Universal; Device: Medlance Plus Extra; Device: Medlance Plus Special |
| HTL-STREFA S.A.safety lancet type 430 | Experimental | Not described Receives: Device: Prolance Micro Flow; Device: Prolance Low Flow; Device: Prolance Normal Flow; Device: Prolance High Flow; Device: Prolance Max Flow; Device: Prolance Pediatric |
| HTL-STREFA S.A.safety lancet type 420 | Experimental | Not described Receives: Device: Haemolance Micro Flow; Device: Haemolance Low Flow; Device: Haemolnace Normal Flow; Device: Haemolance High Flow; Device: Haemolance Max Flow; Device: Haemolance Pediatric |
| HTL-STREFA S.A.safety lancet type 520 | Experimental | Not described Receives: Device: MediSafe Solo 29 Gauge; Device: MediSafe Solo 23 Gauge |
| HTL-STREFA S.A.safety lancet type 450 | Experimental | Not described Receives: Device: ergoLance Micro Flow; Device: ergoLance Normal Flow; Device: ergoLance High Flow |
| HTL-STREFA S.A.safety lancet type 545-549 | Experimental | Not described Receives: Device: Medlance (light blue); Device: Medlance (blue); Device: Medlance (dark blue); Device: Medlance (yellow); Device: Medlance (orange); Device: Medlance (red) |
| Owem Mumford lancet | Experimental | Not described Receives: Device: Unistik 3 Extra; Device: Unistik 3 Comfort; Device: Unistik Touch |
| Medicore lancet | Experimental | Not described Receives: Device: ReadyLance (blue); Device: ReadyLance (orange) |
| Arkray lancet | Experimental | Not described Receives: Device: AssureLance; Device: AssureLance MicroFlow |
| Medipurpose lancet | Experimental | Not described Receives: Device: Surgilance; Device: Surgilance Lite (grey); Device: Surgilance Lite (purple) |
| Sterilance lancet | Experimental | Not described Receives: Device: SteriLance Lite2; Device: SteriLance Press |
| Dynarex lancet | Experimental | Not described Receives: Device: SensiLance (pink); Device: SensiLance (orange) |
| Ypsomed lancet | Experimental | Not described Receives: Device: mylife |
| Promismed lancet | Experimental | Not described Receives: Device: VeriFine |
| Cambridge Sensors lancet | Experimental | Not described Receives: Device: Microdot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume (microliters) of blood in the capillary tube
The amount of capillary blood volume collected after a single lancing of the fingertip.
Measured: 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.
Measured: The blood volume was noted until the end of bleeding or up to 2 minutes time
Secondary outcomes (2)
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.
Measured: directly after lancing
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.
Measured: after 30 minutes ± 5 min after lancing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start8 Dec 2017
- Primary completion17 Dec 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- HTL-Strefa S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752229
- Sponsor's protocol ID
- 02LAN2017
- Status last verified
- Nov 2018
- First submitted
- 20 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03752229
- Acronym / sponsor ID
- 02LAN2017
- Conditions
- Healthy
- Keywords
- safety lancets, lancet, capillary blood, capillary blood sampling, blood volume, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 17 Dec 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| HTL-STREFA S.A.safety lancet type 610 | Experimental | Device: Acti-Lance Lite, Device: Acti-Lance Universal, Device: Acti-Lance Special |
| HTL-STREFA S.A.safety lancet type 553-556 | Experimental | Device: Medlance Plus Super Lite, Device: Medlance Plus Lite, Device: Medlance Plus Universal, Device: Medlance Plus Extra, Device: Medlance Plus Special |
| HTL-STREFA S.A.safety lancet type 430 | Experimental | Device: Prolance Micro Flow, Device: Prolance Low Flow, Device: Prolance Normal Flow, Device: Prolance High Flow, Device: Prolance Max Flow, Device: Prolance Pediatric |
| HTL-STREFA S.A.safety lancet type 420 | Experimental | Device: Haemolance Micro Flow, Device: Haemolance Low Flow, Device: Haemolnace Normal Flow, Device: Haemolance High Flow, Device: Haemolance Max Flow, Device: Haemolance Pediatric |
| HTL-STREFA S.A.safety lancet type 520 | Experimental | Device: MediSafe Solo 29 Gauge, Device: MediSafe Solo 23 Gauge |
| HTL-STREFA S.A.safety lancet type 450 | Experimental | Device: ergoLance Micro Flow, Device: ergoLance Normal Flow, Device: ergoLance High Flow |
| HTL-STREFA S.A.safety lancet type 545-549 | Experimental | Device: Medlance (light blue), Device: Medlance (blue), Device: Medlance (dark blue), Device: Medlance (yellow), Device: Medlance (orange), Device: Medlance (red) |
| Owem Mumford lancet | Experimental | Device: Unistik 3 Extra, Device: Unistik 3 Comfort, Device: Unistik Touch |
| Medicore lancet | Experimental | Device: ReadyLance (blue), Device: ReadyLance (orange) |
| Arkray lancet | Experimental | Device: AssureLance, Device: AssureLance MicroFlow |
| Medipurpose lancet | Experimental | Device: Surgilance, Device: Surgilance Lite (grey), Device: Surgilance Lite (purple) |
| Sterilance lancet | Experimental | Device: SteriLance Lite2, Device: SteriLance Press |
| Dynarex lancet | Experimental | Device: SensiLance (pink), Device: SensiLance (orange) |
| Ypsomed lancet | Experimental | Device: mylife |
| Promismed lancet | Experimental | Device: VeriFine |
| Cambridge Sensors lancet | Experimental | Device: Microdot |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acti-Lance LiteAlso: HTL-STREFA S.A. safety lancet type 610Finger 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. | Device | HTL-STREFA S.A.safety lancet type 610 |
| Acti-Lance UniversalAlso: HTL-STREFA S.A. safety lancet type 610Finger 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. | Device | HTL-STREFA S.A.safety lancet type 610 |
| Acti-Lance SpecialAlso: HTL-STREFA S.A. safety lancet type 610Finger 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. | Device | HTL-STREFA S.A.safety lancet type 610 |
| Medlance Plus Super LiteAlso: HTL-STREFA S.A. safety lancet type 553Finger 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. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus LiteAlso: HTL-STREFA S.A. safety lancet type 553Finger 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. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus UniversalAlso: HTL-STREFA S.A. safety lancet type 554Finger 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. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus ExtraAlso: HTL-STREFA S.A. safety lancet type 555Finger 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. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus SpecialAlso: HTL-STREFA S.A. safety lancet type 556Finger 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. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Prolance Micro FlowAlso: HTL-STREFA S.A. safety lancet type 430Finger 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. | Device | HTL-STREFA S.A.safety lancet type 430 |
| Prolance Low FlowAlso: HTL-STREFA S.A. safety lancet type 430Finger 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. | Device | HTL-STREFA S.A.safety lancet type 430 |
| Prolance Normal FlowAlso: HTL-STREFA S.A. safety lancet type 430Finger 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. | Device | HTL-STREFA S.A.safety lancet type 430 |
| Prolance High FlowAlso: HTL-STREFA S.A. safety lancet type 430Finger 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. | Device | HTL-STREFA S.A.safety lancet type 430 |
| Prolance Max FlowAlso: HTL-STREFA S.A. safety lancet type 430Finger 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. | Device | HTL-STREFA S.A.safety lancet type 430 |
| Prolance PediatricAlso: HTL-STREFA S.A. safety lancet type 430Finger 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. | Device | HTL-STREFA S.A.safety lancet type 430 |
| Haemolance Micro FlowAlso: HTL-STREFA S.A. safety lancet type 420Finger 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. | Device | HTL-STREFA S.A.safety lancet type 420 |
| Haemolance Low FlowAlso: HTL-STREFA S.A. safety lancet type 420Finger 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. | Device | HTL-STREFA S.A.safety lancet type 420 |
| Haemolnace Normal FlowAlso: HTL-STREFA S.A. safety lancet type 420Finger 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. | Device | HTL-STREFA S.A.safety lancet type 420 |
| Haemolance High FlowAlso: HTL-STREFA S.A. safety lancet type 420Finger 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. | Device | HTL-STREFA S.A.safety lancet type 420 |
| Haemolance Max FlowAlso: HTL-STREFA S.A. safety lancet type 420Finger 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. | Device | HTL-STREFA S.A.safety lancet type 420 |
| Haemolance PediatricAlso: HTL-STREFA S.A. safety lancet type 420Finger 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. | Device | HTL-STREFA S.A.safety lancet type 420 |
| MediSafe Solo 29 GaugeAlso: HTL-STREFA S.A. safety lancet type 520Finger 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. | Device | HTL-STREFA S.A.safety lancet type 520 |
| MediSafe Solo 23 GaugeAlso: HTL-STREFA S.A. safety lancet type 520Finger 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. | Device | HTL-STREFA S.A.safety lancet type 520 |
| ergoLance Micro FlowAlso: HTL-STREFA S.A. safety lancet type 450Finger 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. | Device | HTL-STREFA S.A.safety lancet type 450 |
| ergoLance Normal FlowAlso: HTL-STREFA S.A. safety lancet type 450Finger 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. | Device | HTL-STREFA S.A.safety lancet type 450 |
| ergoLance High FlowAlso: HTL-STREFA S.A. safety lancet type 450Finger 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. | Device | HTL-STREFA S.A.safety lancet type 450 |
| Medlance (light blue)Also: HTL-STREFA S.A. safety lancet type 545Finger 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. | Device | HTL-STREFA S.A.safety lancet type 545-549 |
| Medlance (blue)Also: HTL-STREFA S.A. safety lancet type 545Finger 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. | Device | HTL-STREFA S.A.safety lancet type 545-549 |
| Medlance (dark blue)Also: HTL-STREFA S.A. safety lancet type 546Finger 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. | Device | HTL-STREFA S.A.safety lancet type 545-549 |
| Medlance (yellow)Also: HTL-STREFA S.A. safety lancet type 547Finger 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. | Device | HTL-STREFA S.A.safety lancet type 545-549 |
| Medlance (orange)Also: HTL-STREFA S.A. safety lancet type 548Finger 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. | Device | HTL-STREFA S.A.safety lancet type 545-549 |
| Medlance (red)Also: HTL-STREFA S.A. safety lancet type 549Finger 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. | Device | HTL-STREFA S.A.safety lancet type 545-549 |
| Unistik 3 ExtraAlso: Owem Mumford lancetFinger 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. | Device | Owem Mumford lancet |
| Unistik 3 ComfortAlso: Owem Mumford lancetFinger 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. | Device | Owem Mumford lancet |
| Unistik TouchAlso: Owem Mumford lancetFinger 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. | Device | Owem Mumford lancet |
| ReadyLance (blue)Also: Medicore lancetFinger 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. | Device | Medicore lancet |
| ReadyLance (orange)Also: Medicore lancetFinger 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. | Device | Medicore lancet |
| AssureLanceAlso: Arkray lancetFinger 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. | Device | Arkray lancet |
| AssureLance MicroFlowAlso: Arkray lancetFinger 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. | Device | Arkray lancet |
| SurgilanceAlso: Medipurpose lancetFinger 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. | Device | Medipurpose lancet |
| Surgilance Lite (grey)Also: Medipurpose lancetFinger 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. | Device | Medipurpose lancet |
| Surgilance Lite (purple)Also: Medipurpose lancetFinger 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. | Device | Medipurpose lancet |
| SteriLance Lite2Also: Sterilance lancetFinger 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. | Device | Sterilance lancet |
| SensiLance (pink)Also: Dynarex lancetFinger 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. | Device | Dynarex lancet |
| SteriLance PressAlso: Sterilance lancetFinger 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. | Device | Sterilance lancet |
| SensiLance (orange)Also: Dynarex lancetFinger 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. | Device | Dynarex lancet |
| mylifeAlso: Ypsomed lancetFinger 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. | Device | Ypsomed lancet |
| VeriFineAlso: Promismed lancetFinger 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. | Device | Promismed lancet |
| MicrodotAlso: Cambridge Sensors lancetFinger 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. | Device | Cambridge Sensors lancet |
Primary outcome
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.
2 secondary outcomes
Pain perception
Time frame: directly after lancing
Pain perception
Time frame: after 30 minutes ± 5 min after lancing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acti-Lance Lite, Acti-Lance Universal and Acti-Lance Special in people with Healthy, run by HTL-Strefa S.A. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume (microliters) of blood in the capillary tube (time frame: The blood volume was noted after 20 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2018.