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Clinical Trials/CTRI/2024/01/062053
CTRI/2024/01/062053
Not yet recruiting
未知

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 sites0 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: R688- Other general symptoms and signs
Sponsor
Valencell, Inc.
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational

Investigators

Sponsor
Valencell, Inc.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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