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Completed

NCT Number: NCT04001348

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.

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monipol Clinical Pharmacology Research Centre

Krakow, Lesser Poland Voivodeship, 30-969, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to sign the informed consent.
  • Male and female volunteers.
  • Age between 18 and 65 inclusive.
  • Able to communicate well with the Investigator and comply with the requirements of the study.
  • Volunteers who are in good physical and mental health.

Exclusion criteria

  • 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.
  • History of blood borne infection (e.g., HIV, hepatitis B or C, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, T lymphotropic virus Type 1, Creutzfeldt-Jakob disease).
  • Currently participating in another study.
  • History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse.
  • Intake of alcohol within 48 hours prior to the start of the study (self-reporting).
  • Donation or loss of 400 mL or more of blood within 4 weeks prior to the start of the study.
  • Any other condition that in the Investigator opinion may negatively influence Subject's participation in the study.
  • Intake of medicines that affect blood coagulability (including anticoagulants such as vitamin K, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin K antagonists).

Treatment and study plan

Acti-Lance Lite

Device

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 names: HTL-STREFA S.A.safety lancet type 610

Acti-Lance Universal

Device

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 names: HTL-STREFA S.A.safety lancet type 610

Acti-Lance Special

Device

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 names: HTL-STREFA S.A.safety lancet type 610

Medlance Plus Super Lite

Device

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 names: HTL-STREFA S.A.safety lancet type 553-556

Medlance Plus Lite

Device

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 names: HTL-STREFA S.A.safety lancet type 553-556

Medlance Plus Universal

Device

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 names: HTL-STREFA S.A.safety lancet type 553-556

Medlance Plus Extra

Device

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 names: HTL-STREFA S.A.safety lancet type 553-556

Medlance Plus Special

Device

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 names: HTL-STREFA S.A.safety lancet type 553-556

Prolance Micro Flow

Device

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 names: HTL-STREFA S.A.safety lancet type 430

Prolance Low Flow

Device

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 names: HTL-STREFA S.A.safety lancet type 430

Prolance Normal Flow

Device

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 names: HTL-STREFA S.A.safety lancet type 430

Prolance High Flow

Device

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 names: HTL-STREFA S.A.safety lancet type 430

Prolance Max Flow

Device

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 names: HTL-STREFA S.A.safety lancet type 430

Prolance Pediatric

Device

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 names: HTL-STREFA S.A.safety lancet type 430

MediSafe Solo 29 Gauge

Device

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 names: HTL-STREFA S.A.safety lancet type 520

MediSafe Solo 23 Gauge

Device

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 names: HTL-STREFA S.A.safety lancet type 520

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain perception: VAS

    Time frame: 5 minutes after lancing

    The intensity of pain perceived by the patient was assessed with the use of the numeric Visual Analog Scale (VAS). The Subject marked on the scale the number from 0 ("no pain") to 10 ("worst imaginable pain") that represented their perception of pain. A higher score indicated greater pain intensity.

Sponsors and collaborators

Lead sponsor

HTL-Strefa S.A.

Industry

Registry information

Official study title

A 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 28, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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