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

HTL-Strefa

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03752229

02LAN2017

Details and patient eligibility

About

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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 16 patient groups

HTL-STREFA S.A.safety lancet type 610

Experimental group

Treatment:

Device: Acti-Lance Lite

Device: Acti-Lance Universal

Device: Acti-Lance Special

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

Experimental group

Treatment:

Device: Medlance Plus Lite

Device: Medlance Plus Special

Device: Medlance Plus Universal

Device: Medlance Plus Extra

Device: Medlance Plus Super Lite

HTL-STREFA S.A.safety lancet type 430

Experimental group

Treatment:

Device: Prolance Micro Flow

Device: Prolance Normal Flow

Device: Prolance Max Flow

Device: Prolance Low Flow

Device: Prolance Pediatric

Device: Prolance High Flow

HTL-STREFA S.A.safety lancet type 420

Experimental group

Treatment:

Device: Haemolnace Normal Flow

Device: Haemolance Micro Flow

Device: Haemolance High Flow

Device: Haemolance Pediatric

Device: Haemolance Max Flow

Device: Haemolance Low Flow

HTL-STREFA S.A.safety lancet type 520

Experimental group

Treatment:

Device: MediSafe Solo 23 Gauge

Device: MediSafe Solo 29 Gauge

HTL-STREFA S.A.safety lancet type 450

Experimental group

Treatment:

Device: ergoLance Normal Flow

Device: ergoLance Micro Flow

Device: ergoLance High Flow

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

Experimental group

Treatment:

Device: Medlance (orange)

Device: Medlance (dark blue)

Device: Medlance (red)

Device: Medlance (blue)

Device: Medlance (light blue)

Device: Medlance (yellow)

Owem Mumford lancet

Experimental group

Treatment:

Device: Unistik Touch

Device: Unistik 3 Extra

Device: Unistik 3 Comfort

Medicore lancet

Experimental group

Treatment:

Device: ReadyLance (orange)

Device: ReadyLance (blue)

Arkray lancet

Experimental group

Treatment:

Device: AssureLance MicroFlow

Device: AssureLance

Medipurpose lancet

Experimental group

Treatment:

Device: Surgilance Lite (grey)

Device: Surgilance

Device: Surgilance Lite (purple)

Sterilance lancet

Experimental group

Treatment:

Device: SteriLance Press

Device: SteriLance Lite2

Dynarex lancet

Experimental group

Treatment:

Device: SensiLance (orange)

Device: SensiLance (pink)

Ypsomed lancet

Experimental group

Treatment:

Device: mylife

Promismed lancet

Experimental group

Treatment:

Device: VeriFine

Cambridge Sensors lancet

Experimental group

Treatment:

Device: Microdot