Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
NCT ID: NCT04001348
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2013-06-30
2013-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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HTL-STREFA S.A.safety lancet type 610
Acti-Lance Lite
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 Universal
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 Special
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.
HTL-STREFA S.A.safety lancet type 553-556
Medlance Plus Super Lite
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 Lite
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 Universal
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 Extra
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 Special
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.
HTL-STREFA S.A.safety lancet type 430
Prolance Micro Flow
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 Flow
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 Flow
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 Flow
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 Flow
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 Pediatric
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.
HTL-STREFA S.A.safety lancet type 520
MediSafe Solo 29 Gauge
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 Gauge
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.
Interventions
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Acti-Lance Lite
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 Universal
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 Special
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 Lite
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 Lite
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 Universal
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 Extra
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 Special
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 Flow
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 Flow
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 Flow
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 Flow
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 Flow
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 Pediatric
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 Gauge
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 Gauge
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
65 Years
ALL
Yes
Sponsors
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HTL-Strefa S.A.
INDUSTRY
Responsible Party
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Locations
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Monipol Clinical Pharmacology Research Centre
Krakow, Lesser Poland Voivodeship, Poland
Countries
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References
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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.
Other Identifiers
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Mp05.13
Identifier Type: -
Identifier Source: org_study_id