Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets

NCT ID: NCT03752229

Last Updated: 2018-11-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-08

Study Completion Date

2018-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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HTL-STREFA S.A.safety lancet type 610

Group Type EXPERIMENTAL

Acti-Lance Lite

Intervention Type 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.

Acti-Lance Universal

Intervention Type 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.

Acti-Lance Special

Intervention Type 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.

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

Group Type EXPERIMENTAL

Medlance Plus Super Lite

Intervention Type 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.

Medlance Plus Lite

Intervention Type 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.

Medlance Plus Universal

Intervention Type 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.

Medlance Plus Extra

Intervention Type 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.

Medlance Plus Special

Intervention Type 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.

HTL-STREFA S.A.safety lancet type 430

Group Type EXPERIMENTAL

Prolance Micro Flow

Intervention Type 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.

Prolance Low Flow

Intervention Type 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.

Prolance Normal Flow

Intervention Type 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.

Prolance High Flow

Intervention Type 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.

Prolance Max Flow

Intervention Type 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.

Prolance Pediatric

Intervention Type 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.

HTL-STREFA S.A.safety lancet type 420

Group Type EXPERIMENTAL

Haemolance Micro Flow

Intervention Type 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.

Haemolance Low Flow

Intervention Type 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.

Haemolnace Normal Flow

Intervention Type 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.

Haemolance High Flow

Intervention Type 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.

Haemolance Max Flow

Intervention Type 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.

Haemolance Pediatric

Intervention Type 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.

HTL-STREFA S.A.safety lancet type 520

Group Type EXPERIMENTAL

MediSafe Solo 29 Gauge

Intervention Type 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.

MediSafe Solo 23 Gauge

Intervention Type 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.

HTL-STREFA S.A.safety lancet type 450

Group Type EXPERIMENTAL

ergoLance Micro Flow

Intervention Type 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.

ergoLance Normal Flow

Intervention Type 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.

ergoLance High Flow

Intervention Type 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.

HTL-STREFA S.A.safety lancet type 545-549

Group Type EXPERIMENTAL

Medlance (light blue)

Intervention Type 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.

Medlance (blue)

Intervention Type 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.

Medlance (dark blue)

Intervention Type 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.

Medlance (yellow)

Intervention Type 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.

Medlance (orange)

Intervention Type 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.

Medlance (red)

Intervention Type 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.

Owem Mumford lancet

Group Type EXPERIMENTAL

Unistik 3 Extra

Intervention Type 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.

Unistik 3 Comfort

Intervention Type 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.

Unistik Touch

Intervention Type 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.

Medicore lancet

Group Type EXPERIMENTAL

ReadyLance (blue)

Intervention Type 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.

ReadyLance (orange)

Intervention Type 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.

Arkray lancet

Group Type EXPERIMENTAL

AssureLance

Intervention Type 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.

AssureLance MicroFlow

Intervention Type 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.

Medipurpose lancet

Group Type EXPERIMENTAL

Surgilance

Intervention Type 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.

Surgilance Lite (grey)

Intervention Type 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.

Surgilance Lite (purple)

Intervention Type 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.

Sterilance lancet

Group Type EXPERIMENTAL

SteriLance Lite2

Intervention Type 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.

SteriLance Press

Intervention Type 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.

Dynarex lancet

Group Type EXPERIMENTAL

SensiLance (pink)

Intervention Type 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.

SensiLance (orange)

Intervention Type 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.

Ypsomed lancet

Group Type EXPERIMENTAL

mylife

Intervention Type 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.

Promismed lancet

Group Type EXPERIMENTAL

VeriFine

Intervention Type 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.

Cambridge Sensors lancet

Group Type EXPERIMENTAL

Microdot

Intervention Type 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.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Haemolance 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.

Intervention Type DEVICE

Haemolance 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.

Intervention Type DEVICE

Haemolnace 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.

Intervention Type DEVICE

Haemolance 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.

Intervention Type DEVICE

Haemolance 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.

Intervention Type DEVICE

Haemolance 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

ergoLance 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.

Intervention Type DEVICE

ergoLance 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.

Intervention Type DEVICE

ergoLance 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.

Intervention Type DEVICE

Medlance (light blue)

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.

Intervention Type DEVICE

Medlance (blue)

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.

Intervention Type DEVICE

Medlance (dark blue)

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.

Intervention Type DEVICE

Medlance (yellow)

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.

Intervention Type DEVICE

Medlance (orange)

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.

Intervention Type DEVICE

Medlance (red)

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.

Intervention Type DEVICE

Unistik 3 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.

Intervention Type DEVICE

Unistik 3 Comfort

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.

Intervention Type DEVICE

Unistik Touch

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.

Intervention Type DEVICE

ReadyLance (blue)

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.

Intervention Type DEVICE

ReadyLance (orange)

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.

Intervention Type DEVICE

AssureLance

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.

Intervention Type DEVICE

AssureLance MicroFlow

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.

Intervention Type DEVICE

Surgilance

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.

Intervention Type DEVICE

Surgilance Lite (grey)

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.

Intervention Type DEVICE

Surgilance Lite (purple)

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.

Intervention Type DEVICE

SteriLance Lite2

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.

Intervention Type DEVICE

SensiLance (pink)

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.

Intervention Type DEVICE

SteriLance Press

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.

Intervention Type DEVICE

SensiLance (orange)

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.

Intervention Type DEVICE

mylife

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.

Intervention Type DEVICE

VeriFine

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.

Intervention Type DEVICE

Microdot

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.

Intervention Type DEVICE

Other Intervention Names

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HTL-STREFA S.A. safety lancet type 610 HTL-STREFA S.A. safety lancet type 610 HTL-STREFA S.A. safety lancet type 610 HTL-STREFA S.A. safety lancet type 553 HTL-STREFA S.A. safety lancet type 553 HTL-STREFA S.A. safety lancet type 554 HTL-STREFA S.A. safety lancet type 555 HTL-STREFA S.A. safety lancet type 556 HTL-STREFA S.A. safety lancet type 430 HTL-STREFA S.A. safety lancet type 430 HTL-STREFA S.A. safety lancet type 430 HTL-STREFA S.A. safety lancet type 430 HTL-STREFA S.A. safety lancet type 430 HTL-STREFA S.A. safety lancet type 430 HTL-STREFA S.A. safety lancet type 420 HTL-STREFA S.A. safety lancet type 420 HTL-STREFA S.A. safety lancet type 420 HTL-STREFA S.A. safety lancet type 420 HTL-STREFA S.A. safety lancet type 420 HTL-STREFA S.A. safety lancet type 420 HTL-STREFA S.A. safety lancet type 520 HTL-STREFA S.A. safety lancet type 520 HTL-STREFA S.A. safety lancet type 450 HTL-STREFA S.A. safety lancet type 450 HTL-STREFA S.A. safety lancet type 450 HTL-STREFA S.A. safety lancet type 545 HTL-STREFA S.A. safety lancet type 545 HTL-STREFA S.A. safety lancet type 546 HTL-STREFA S.A. safety lancet type 547 HTL-STREFA S.A. safety lancet type 548 HTL-STREFA S.A. safety lancet type 549 Owem Mumford lancet Owem Mumford lancet Owem Mumford lancet Medicore lancet Medicore lancet Arkray lancet Arkray lancet Medipurpose lancet Medipurpose lancet Medipurpose lancet Sterilance lancet Dynarex lancet Sterilance lancet Dynarex lancet Ypsomed lancet Promismed lancet Cambridge Sensors lancet

Eligibility Criteria

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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

* 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
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HTL-Strefa S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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BioResearch Group Sp. z o.o.

Nadarzyn, Masovian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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02LAN2017

Identifier Type: -

Identifier Source: org_study_id

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