Fresenius Noninvasive Blood Pressure Validation - Three Phase Study PR 2020-377
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Validation of Blood Pressure Module (BPM) and Cuffs on the Fresenius Hemodialysis Machine
研究概览
简要总结
The purpose of this study to collect blood pressure measurement values from the blood pressure measurement device on the Fresenius machine as compared to the standard method.
详细描述
This study is a comparative, single-center, non-randomized comparative study. After IRB approval, the study will be conducted in three Phases. The Fresenius 5008S BPM Module and Cuffs will be evaluated on a minimum of 120 subjects. Three reports will be generated and submitted to different regulatory bodies with the following minimum subject demographics:
- Phase 1: The submission to the United States Food and Drug Administration will include 85 adult and adolescents ages 13 and older.
- Phase 2: The submission to European agencies will contain 50 adult and adolescents ages 13 and older and 35 pediatric subjects ages 3-12.
- Phase 3: The submission to the China Food and Drug Administration will contain 73 adult and adolescents ages 13 and older and 12 pediatric subjects ages 3-12.
Each subject test is expected to take up to 1 hour. Data collection is expected to take 3-6 weeks for Phase 1. Phase 2 and 3 are expected to take an additional 2-4 weeks.
The Auscultator will have a normal audiogram before the study begins. All experimenters will review the protocol prior to test.
Testing will be conducted under normal office environment conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able to provide an informed consent or have legally authorized representative consent to participate.
- •Subject must be willing and able to comply with the study procedures.
- •Subjects must be ≥ 13 years of age for Phase
- •Subjects must be ≥ 3 years of age for Phase 2 and
- •Subjects that are between 7 and 17 years of age must provide Assent to participate in the study.
- •Subject or legally authorized representative must be able to read or write in English.
- •Subjects must have an arm circumference in the range of 13-55cm or a thigh circumference in the range of 50-70 cm circumference.
- •At least 30% of subjects shall be male and at least 30% of subjects shall be female.
排除标准
- •Lack of Informed Consent
- •Subjects with deformities or abnormalities that may prevent proper application of the Device Under Test.
- •Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
- •Subjects with known heart dysrhythmias.
- •Subjects with compromised circulation or peripheral vascular disease.
- •Subjects with clotting disorders or taking blood thinners.
- •Subjects that cannot tolerate sitting for up to 1 hour.
- •Subject with a blood pressure demographic that has already been filled.
结局指标
主要结局
Validation of Blood Pressure Module (BPM) and Cuffs on the Fresenius Hemodialysis Machine
时间窗: Baseline Comparator
The Fresenius 5008S BPM with cuffs will be compared to the Reference sphygmomanometer via dual auscultator method. This will be a one-time measurement only no patient follow-up will be performed.
次要结局
未报告次要终点