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.

Valencell, Inc.0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年3月4日

试验速览

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•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.

•Lack of Informed consent.
•Participants with deformities or abnormalities that may prevent proper application of the device under test.
•Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
•Participants with known heart dysrhythmias.
•Participants with compromised circulation or peripheral vascular disease.
•Participants who are pregnant and/or lactating.
•Participants who cannot tolerate sitting for up to 30 minutes.
•Participant falls into a category that has already been filled

发起方

Valencell, Inc.