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

HTL-Strefa

Status: Completed

Conditions: Healthy

Treatments: Device: Medlance Plus Extra; Device: Acti-Lance Universal; Device: MediSafe Solo 29 Gauge; Device: Medlance Plus Super Lite; Device: Prolance Pediatric; Device: Prolance Max Flow; Device: Prolance Low Flow; Device: Prolance High Flow; Device: Medlance Plus Universal; Device: Acti-Lance Lite; Device: Medlance Plus Special; Device: Prolance Normal Flow; Device: MediSafe Solo 23 Gauge; Device: Acti-Lance Special; Device: Prolance Micro Flow; Device: Medlance Plus Lite

Study type: Interventional

Funder types: Industry

Identifiers

NCT04001348

Mp05.13

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 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.

Enrollment: 100 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

• 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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups

HTL-STREFA S.A.safety lancet type 610

Experimental group

Treatment:

Device: Acti-Lance Special

Device: Acti-Lance Lite

Device: Acti-Lance Universal

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 Super Lite

Device: Medlance Plus Extra

HTL-STREFA S.A.safety lancet type 430

Experimental group

Treatment:

Device: Prolance Micro Flow

Device: Prolance Normal Flow

Device: Prolance High Flow

Device: Prolance Low Flow

Device: Prolance Max Flow

Device: Prolance Pediatric

HTL-STREFA S.A.safety lancet type 520

Experimental group

Treatment:

Device: MediSafe Solo 23 Gauge

Device: MediSafe Solo 29 Gauge