Status:
COMPLETED
Capillary Blood Volume and Pain Perception Obtained in a Process of Puncturing With Different Safety Lancets
Lead Sponsor:
HTL-Strefa S.A.
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
NA
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 wi...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03752229
Start Date
December 8 2017
End Date
January 30 2018
Last Update
November 26 2018
Active Locations (1)
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1
BioResearch Group Sp. z o.o.
Nadarzyn, Masovian Voivodeship, Poland, 05-830