Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers

June 27, 2019 updated by: HTL-Strefa S.A.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolskie
      • Cracovia, Malopolskie, Poland, 30-969
        • Monipol Clinical Pharmacology Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HTL-STREFA S.A.safety lancet type 610
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 610
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 610
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 610
Experimental: HTL-STREFA S.A.safety lancet type 553-556
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 553-556
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 553-556
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 553-556
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 553-556
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 553-556
Experimental: HTL-STREFA S.A.safety lancet type 430
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 430
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 430
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 430
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 430
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 430
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 430
Experimental: HTL-STREFA S.A.safety lancet type 520
Device: 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.

Other Names:
  • HTL-STREFA S.A.safety lancet type 520
Device: 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 Names:
  • HTL-STREFA S.A.safety lancet type 520

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volume (microliters) of blood in the capillary tube
Time Frame: The blood 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.
The blood from the puncture site was collected to the capillaries by pressing during 2 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 minutes after lancing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HTL-Strefa S.A.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 26, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

June 28, 2019

Study Record Updates

Last Update Posted (Actual)

June 28, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Mp05.13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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