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

Not Applicable

Completed

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

• Registration Number: NCT04001348
• Lead Sponsor: HTL-Strefa S.A.

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2019-06
• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-06-27
• Last Update Submitted: 2019-06-27
• Study First Posted: 2019-06-28
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Extra	-
HTL-STREFA S.A.safety lancet type 430	Prolance Micro Flow	-
HTL-STREFA S.A.safety lancet type 430	Prolance Max Flow	-
HTL-STREFA S.A.safety lancet type 610	Acti-Lance Lite	-
HTL-STREFA S.A.safety lancet type 610	Acti-Lance Universal	-
HTL-STREFA S.A.safety lancet type 430	Prolance Low Flow	-
HTL-STREFA S.A.safety lancet type 430	Prolance Pediatric	-
HTL-STREFA S.A.safety lancet type 610	Acti-Lance Special	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Super Lite	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Lite	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Universal	-
HTL-STREFA S.A.safety lancet type 430	Prolance Normal Flow	-
HTL-STREFA S.A.safety lancet type 520	MediSafe Solo 23 Gauge	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Special	-
HTL-STREFA S.A.safety lancet type 430	Prolance High Flow	-
HTL-STREFA S.A.safety lancet type 520	MediSafe Solo 29 Gauge	-

Primary Outcome Measures

Name	Time	Method
Volume (microliters) of blood in the capillary tube	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.

Secondary Outcome Measures

Name	Time	Method
Pain perception: VAS	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.

Trial Locations

Locations (1)

Monipol Clinical Pharmacology Research Centre; 🇵🇱 Cracovia, Malopolskie, Poland