A prospective observational study for the development of accuracy data to support the development of Valencell finger clip and watch blood pressure systems using same arm sequential method.
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Valencell, Inc.
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- 1.Photoplethysmography (PPG) developmental data for the Valencell prototype finger clip and watch blood pressure systems on the intended population.
概览
简要总结
The PPG technology enables continuous and non-invasive blood pressure measurement using wearable devices. The PPG signals are easily acquired from an optical sensor of a wearable device applied to the epidermis and used to estimate blood pressure. This principle is used for the development of various new instruments and sensor-based systems which are integrated with computer-based healthcare systems to support continuous and remote monitoring of assisted living
The study is being done for the development of non-invasive accuracy data of systolic and diastolic blood pressure measurements to support the development of wearable finger clips and watch blood pressure systems in adults. The device under test will be built according to the Valencell design control processes.
The device will include the Valencell prototype finger clip and watch connected to a laptop via USB through a Valencell USB development platform. Device model numbers, serial numbers, date(s) of use, participant ID number(s) will be recorded on the Case Report Forms.
The sensor clip will be applied to the finger and the watch is applied to the wrist. Once the data collection is done, they will remove. The maximum duration it will take is of 30 minutes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participants must be able to provide an informed consent or have legally authorized representative consent to participate.
- •2.Participant must be willing and able to comply with the study procedures.
- •3.Participant must be ≥ 18 years of age.
- •4.Participants with a upper arm circumference in the range of the reference cuff 5.Participants who fit in one of the following categories with a goal of 15% minimum in each and up to 15% can fall outside of these categories: a.Age Group 18-30: Any BP systolic over 140 mmHg. b.Age Group 18-30: Overweight(BMI>25) with BP systolic under 100 mmHg. c.Age Group 30+: Any with BP systolic over 160 mmHg. d.Age Group 30+: Any with BP systolic under 100 mmHg. e.Age Group 18+: With any BP.
排除标准
- •â€¢ Lack of Informed consent.
- •â€¢ Participants with deformities or abnormalities that may prevent proper application of the device under test.
- •â€¢ Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
- •â€¢ Participants with known heart dysrhythmias.
- •â€¢ Participants with compromised circulation or peripheral vascular disease.
- •â€¢ Participants who are pregnant and/or lactating.
- •â€¢ Participants who cannot tolerate sitting for up to 30 minutes.
- •â€¢ Participant falls into a category that has already been filled.
结局指标
主要结局
1.Photoplethysmography (PPG) developmental data for the Valencell prototype finger clip and watch blood pressure systems on the intended population.
时间窗: Day 1 (Single visit study- 03 reading within 30 mins)
2.Systolic and diastolic blood pressure as measured by Reference sphygmomanometer.
时间窗: Day 1 (Single visit study- 03 reading within 30 mins)
次要结局
- NA(NA)
研究者
Dr Rajneesh kapoor
Medanta The Medicity