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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Volume (microliters) of blood in the capillary tube
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Volume (microliters) of blood in the capillary tube
时间窗: 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.
次要结局
- Pain perception(after 30 minutes ± 5 min after lancing)