A Single-blind, Randomized, Uni-centre Study to Determine the Characteristics of Different Types of Safety Lancets on Blood Volume and Perceived Pain in Male and Female Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 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 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.
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
- •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).
研究组 & 干预措施
HTL-STREFA S.A.safety lancet type 610
干预措施: Acti-Lance Lite (Device)
HTL-STREFA S.A.safety lancet type 610
干预措施: Acti-Lance Universal (Device)
HTL-STREFA S.A.safety lancet type 610
干预措施: Acti-Lance Special (Device)
HTL-STREFA S.A.safety lancet type 553-556
干预措施: Medlance Plus Super Lite (Device)
HTL-STREFA S.A.safety lancet type 553-556
干预措施: Medlance Plus Lite (Device)
HTL-STREFA S.A.safety lancet type 553-556
干预措施: Medlance Plus Universal (Device)
HTL-STREFA S.A.safety lancet type 553-556
干预措施: Medlance Plus Extra (Device)
HTL-STREFA S.A.safety lancet type 553-556
干预措施: Medlance Plus Special (Device)
HTL-STREFA S.A.safety lancet type 430
干预措施: Prolance Micro Flow (Device)
HTL-STREFA S.A.safety lancet type 430
干预措施: Prolance Low Flow (Device)
HTL-STREFA S.A.safety lancet type 430
干预措施: Prolance Normal Flow (Device)
HTL-STREFA S.A.safety lancet type 430
干预措施: Prolance High Flow (Device)
HTL-STREFA S.A.safety lancet type 430
干预措施: Prolance Max Flow (Device)
HTL-STREFA S.A.safety lancet type 430
干预措施: Prolance Pediatric (Device)
HTL-STREFA S.A.safety lancet type 520
干预措施: MediSafe Solo 29 Gauge (Device)
HTL-STREFA S.A.safety lancet type 520
干预措施: MediSafe Solo 23 Gauge (Device)
结局指标
主要结局
Volume (microliters) of blood in the capillary tube
时间窗: 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.
次要结局
- Pain perception: VAS(5 minutes after lancing)