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

Not Applicable

Completed

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

• Registration Number: NCT03752229
• 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 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

Not available

Study Timeline

• Study Start: 2017-12-08
• Primary Completion: 2017-12-17
• Study Completion: 2018-01-30
• Status Verified: 2018-11
• Study First Submitted: 2018-11-20
• Study First Submitted QC: 2018-11-21
• Last Update Submitted: 2018-11-22
• Study First Posted: 2018-11-23
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HTL-STREFA S.A.safety lancet type 450	ergoLance Normal Flow	-
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 420	Haemolance Micro 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 610	Acti-Lance Special	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Universal	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Extra	-
HTL-STREFA S.A.safety lancet type 430	Prolance Low Flow	-
HTL-STREFA S.A.safety lancet type 430	Prolance High Flow	-
HTL-STREFA S.A.safety lancet type 420	Haemolance High Flow	-
HTL-STREFA S.A.safety lancet type 545-549	Medlance (light blue)	-
HTL-STREFA S.A.safety lancet type 545-549	Medlance (orange)	-
Medicore lancet	ReadyLance (blue)	-
Medicore lancet	ReadyLance (orange)	-
HTL-STREFA S.A.safety lancet type 553-556	Medlance Plus Special	-
HTL-STREFA S.A.safety lancet type 430	Prolance Micro Flow	-
HTL-STREFA S.A.safety lancet type 430	Prolance Normal Flow	-
HTL-STREFA S.A.safety lancet type 420	Haemolance Low Flow	-
HTL-STREFA S.A.safety lancet type 450	ergoLance Micro Flow	-
HTL-STREFA S.A.safety lancet type 450	ergoLance High Flow	-
HTL-STREFA S.A.safety lancet type 545-549	Medlance (yellow)	-
Owem Mumford lancet	Unistik 3 Extra	-
Owem Mumford lancet	Unistik Touch	-
HTL-STREFA S.A.safety lancet type 430	Prolance Max Flow	-
HTL-STREFA S.A.safety lancet type 430	Prolance Pediatric	-
HTL-STREFA S.A.safety lancet type 520	MediSafe Solo 29 Gauge	-
Arkray lancet	AssureLance MicroFlow	-
Sterilance lancet	SteriLance Press	-
Cambridge Sensors lancet	Microdot	-
HTL-STREFA S.A.safety lancet type 420	Haemolnace Normal Flow	-
HTL-STREFA S.A.safety lancet type 420	Haemolance Max Flow	-
HTL-STREFA S.A.safety lancet type 420	Haemolance Pediatric	-
HTL-STREFA S.A.safety lancet type 520	MediSafe Solo 23 Gauge	-
HTL-STREFA S.A.safety lancet type 545-549	Medlance (blue)	-
HTL-STREFA S.A.safety lancet type 545-549	Medlance (red)	-
Owem Mumford lancet	Unistik 3 Comfort	-
Arkray lancet	AssureLance	-
Medipurpose lancet	Surgilance Lite (purple)	-
HTL-STREFA S.A.safety lancet type 545-549	Medlance (dark blue)	-
Medipurpose lancet	Surgilance Lite (grey)	-
Ypsomed lancet	mylife	-
Medipurpose lancet	Surgilance	-
Sterilance lancet	SteriLance Lite2	-
Dynarex lancet	SensiLance (pink)	-
Dynarex lancet	SensiLance (orange)	-
Promismed lancet	VeriFine	-

Primary Outcome Measures

Name	Time	Method
Volume (microliters) of blood in the capillary tube	The blood volume was noted until the end of bleeding or up to 2 minutes time	The amount of capillary blood volume collected after a single lancing of the fingertip.

Secondary Outcome Measures

Name	Time	Method
Pain perception	after 30 minutes ± 5 min 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)

BioResearch Group Sp. z o.o.; 🇵🇱 Nadarzyn, Mazowieckie, Poland