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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752229
• Other study ID #: 02LAN2017
• Status: Completed
• Phase: N/A
• Start date: December 8, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: November 2018
• Source: HTL-Strefa S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 30, 2018
• Est. primary completion date: December 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
Poland	BioResearch Group Sp. z o.o.	Nadarzyn	Mazowieckie

Sponsors (1)

Lead Sponsor	Collaborator
HTL-Strefa S.A.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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