HealthyNCT04001348
Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
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
- 100 participants
- Where
- 1 sitePoland
- Study dates
- Jun 2013to Jul 2013
- 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
- Pregnancy or breastfeeding (self-reported).
- Confirmed or suspected malignant cancer 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.
Show all 13Show fewer
- 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
Monipol Clinical Pharmacology Research Centre
Krakow, Lesser Poland Voivodeship, 30-969
About this study
Official title: A Single-blind, Randomized, Uni-centre Study to Determine the Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
The study was a randomized, single blind, uni-center pivotal study in male and female healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets.
A group of one hundred (100) healthy Caucasian male and female Subjects (aged > 18 to < 65 years old was randomized ) who were in good physical and mental condition. The Subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. Overall, 4 (four) different safety lancets were investigated per each Subject.
Overall, 16 (sixteen) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.
- 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Medlance Plus Super LiteDevice
Also called HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Medlance Plus LiteDevice
Also called HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Medlance Plus UniversalDevice
Also called HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Medlance Plus ExtraDevice
Also called HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
Medlance Plus SpecialDevice
Also called HTL-STREFA S.A.safety lancet type 553-556
Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure.
| 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 520 | Experimental | Not described Receives: Device: MediSafe Solo 29 Gauge; Device: MediSafe Solo 23 Gauge |
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 from the puncture site was collected to the capillaries by pressing during 2 minutes
Secondary outcomes (1)
Pain perception: VAS
The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.
Measured: 5 minutes after lancing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 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
- NCT04001348
- Sponsor's protocol ID
- Mp05.13
- Status last verified
- Jun 2019
- First submitted
- 26 Jun 2019
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Serafin A, Malinowski M, Prazmowska-Wilanowska A. Blood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal? Postgrad Med. 2020 Apr;132(3):288-295. doi: 10.1080/00325481.2020.1717160. Epub 2020 Feb 6.
PubMed 32027205
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomized, Uni-centre Study to Determine the Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
- ClinicalTrials.gov ID
- NCT04001348
- Acronym / sponsor ID
- Mp05.13
- Conditions
- Healthy
- Keywords
- safety lancets, lancet, capillary blood, capillary blood sampling, blood volume, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- HTL-Strefa S.A.Industry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Jun 2019 (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 one hundred (100) healthy Caucasian male and female Subjects (aged > 18 to < 65 years old was randomized ) who were in good physical and mental condition. The Subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. Overall, 4 (four) different safety lancets were investigated per each Subject.
Overall, 16 (sixteen) different safety lancets (4 different safety lancets per one Subject) were investigated, the capillary blood volume and pain were measured.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| 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 520 | Experimental | Device: MediSafe Solo 29 Gauge, Device: MediSafe Solo 23 Gauge |
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 (13 listed)
- Pregnancy or breastfeeding (self-reported).
- Confirmed or suspected malignant cancer 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.
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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 610 |
| Medlance Plus Super LiteAlso: HTL-STREFA S.A.safety lancet type 553-556Finger 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus LiteAlso: HTL-STREFA S.A.safety lancet type 553-556Finger 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus UniversalAlso: HTL-STREFA S.A.safety lancet type 553-556Finger 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus ExtraAlso: HTL-STREFA S.A.safety lancet type 553-556Finger 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 553-556 |
| Medlance Plus SpecialAlso: HTL-STREFA S.A.safety lancet type 553-556Finger 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 430 |
| 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | 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. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure. | Device | HTL-STREFA S.A.safety lancet type 520 |
Primary outcome
Volume (microliters) of blood in the capillary tube
Time frame: The blood from the puncture site was collected to the capillaries by pressing during 2 minutes
The amount of capillary blood volume collected after a single lancing of the fingertip.
1 secondary outcome
Pain perception: VAS
Time frame: 5 minutes 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 28 Jun 2019.
- Derived from this study: PubMed 32027205Serafin A, Malinowski M, Prazmowska-Wilanowska A. Blood volume and pain perception during finger prick capillary blood sampling: are all safety lancets equal? Postgrad Med. 2020 Apr;132(3):288-295. doi: 10.1080/00325481.2020.1717160. Epub 2020 Feb 6.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 13 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 28 Jun 2019. 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 from the puncture site was collected to the capillaries by pressing during 2 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04001348, which also lists 1 linked publication.
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 28 Jun 2019.