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

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
A Randomized, Single Blind, Uni-centre Study in Healthy Volunteers, to Determine Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Acti-Lance Lite
* Device: Acti-Lance Universal
* Device: Acti-Lance Special
* Device: Medlance Plus Super Lite
* Device: Medlance Plus Lite
* Device: Medlance Plus Universal
* Device: Medlance Plus Extra
* Device: Medlance Plus Special
* Device: Prolance Micro Flow
* Device: Prolance Low Flow
* Device: Prolance Normal Flow
* Device: Prolance High Flow
* Device: Prolance Max Flow
* Device: Prolance Pediatric
* Device: Haemolance Micro Flow
* Device: Haemolance Low Flow
* Device: Haemolnace Normal Flow
* Device: Haemolance High Flow
* Device: Haemolance Max Flow
* Device: Haemolance Pediatric
* Device: MediSafe Solo 29 Gauge
* Device: MediSafe Solo 23 Gauge
* Device: ergoLance Micro Flow
* Device: ergoLance Normal Flow
* Device: ergoLance High Flow
* Device: Medlance (light blue)
* Device: Medlance (blue)
* Device: Medlance (dark blue)
* Device: Medlance (yellow)
* Device: Medlance (orange)
* Device: Medlance (red)
* Device: Unistik 3 Extra
* Device: Unistik 3 Comfort
* Device: Unistik Touch
* Device: ReadyLance (blue)
* Device: ReadyLance (orange)
* Device: AssureLance
* Device: AssureLance MicroFlow
* Device: Surgilance
* Device: Surgilance Lite (grey)
* Device: Surgilance Lite (purple)
* Device: SteriLance Lite2
* Device: SensiLance (pink)
* Device: SteriLance Press
* Device: SensiLance (orange)
* Device: mylife
* Device: VeriFine
* Device: Microdot


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HTL-STREFA S.A.safety lancet type 610<br> | Device: Acti-Lance Lite<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 610;Device: Acti-Lance Universal<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 610;Device: Acti-Lance Special<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 610;|
| Experimental: HTL-STREFA S.A.safety lancet type 553-556<br> | Device: Medlance Plus Super Lite<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 553;Device: Medlance Plus Lite<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 553;Device: Medlance Plus Universal<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 554;Device: Medlance Plus Extra<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 555;Device: Medlance Plus Special<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 556;|
| Experimental: HTL-STREFA S.A.safety lancet type 430<br> | Device: Prolance Micro Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 430;Device: Prolance Low Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 430;Device: Prolance Normal Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 430;Device: Prolance High Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 430;Device: Prolance Max Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 430;Device: Prolance Pediatric<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 430;|
| Experimental: HTL-STREFA S.A.safety lancet type 420<br> | Device: Haemolance Micro Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 420;Device: Haemolance Low Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 420;Device: Haemolnace Normal Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 420;Device: Haemolance High Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 420;Device: Haemolance Max Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 420;Device: Haemolance Pediatric<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 420;|
| Experimental: HTL-STREFA S.A.safety lancet type 520<br> | Device: MediSafe Solo 29 Gauge<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 520;Device: MediSafe Solo 23 Gauge<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 520;|
| Experimental: HTL-STREFA S.A.safety lancet type 450<br> | Device: ergoLance Micro Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 450;Device: ergoLance Normal Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 450;Device: ergoLance High Flow<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 450;|
| Experimental: HTL-STREFA S.A.safety lancet type 545-549<br> | Device: Medlance (light blue)<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 545;Device: Medlance (blue)<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 545;Device: Medlance (dark blue)<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 546;Device: Medlance (yellow)<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 547;Device: Medlance (orange)<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 548;Device: Medlance (red)<br>* 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.<br>* Other names: HTL-STREFA S.A. safety lancet type 549;|
| Experimental: Owem Mumford lancet<br> | Device: Unistik 3 Extra<br>* 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.<br>* Other names: Owem Mumford lancet;Device: Unistik 3 Comfort<br>* 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.<br>* Other names: Owem Mumford lancet;Device: Unistik Touch<br>* 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.<br>* Other names: Owem Mumford lancet;|
| Experimental: Medicore lancet<br> | Device: ReadyLance (blue)<br>* 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.<br>* Other names: Medicore lancet;Device: ReadyLance (orange)<br>* 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.<br>* Other names: Medicore lancet;|
| Experimental: Arkray lancet<br> | Device: AssureLance<br>* 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.<br>* Other names: Arkray lancet;Device: AssureLance MicroFlow<br>* 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.<br>* Other names: Arkray lancet;|
| Experimental: Medipurpose lancet<br> | Device: Surgilance<br>* 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.<br>* Other names: Medipurpose lancet;Device: Surgilance Lite (grey)<br>* 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.<br>* Other names: Medipurpose lancet;Device: Surgilance Lite (purple)<br>* 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.<br>* Other names: Medipurpose lancet;|
| Experimental: Sterilance lancet<br> | Device: SteriLance Lite2<br>* 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.<br>* Other names: Sterilance lancet;Device: SteriLance Press<br>* 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.<br>* Other names: Sterilance lancet;|
| Experimental: Dynarex lancet<br> | Device: SensiLance (pink)<br>* 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.<br>* Other names: Dynarex lancet;Device: SensiLance (orange)<br>* 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.<br>* Other names: Dynarex lancet;|
| Experimental: Ypsomed lancet<br> | Device: mylife<br>* 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.<br>* Other names: Ypsomed lancet;|
| Experimental: Promismed lancet<br> | Device: VeriFine<br>* 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.<br>* Other names: Promismed lancet;|
| Experimental: Cambridge Sensors lancet<br> | Device: Microdot<br>* 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.<br>* Other names: Cambridge Sensors lancet;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume (microliters) of blood in the capillary tube | The amount of capillary blood volume collected after a single lancing of the fingertip. | The blood volume was noted after 20 seconds | 
| Volume (microliters) of blood in the capillary tube | The amount of capillary blood volume collected after a single lancing of the fingertip. | The blood volume was noted until the end of bleeding or up to 2 minutes time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain perception | 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. | directly after lancing | 
| Pain perception | 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. | after 30 minutes ± 5 min after lancing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety lancets, lancet, capillary blood, capillary blood sampling, blood volume, pain