Comparison of Non-Invasive Blood Pressure Methods
Completed · Not applicable
Conditions studied: Blood Pressure
In brief
The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer. The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.
Key facts
- Study ID
- NCT04296227
- Run by
- Vital USA, Inc.
- People needed
- 85
- Starts
- 2020-02-04
- Expected to finish
- 2020-03-03
- Last updated by the study team
- 2020-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
- Subject must be ≥ 18
- Subject or legally authorized representative must be able to read or write in English.
- Subjects with a finger circumference < 8.3 cm.in the range of 10-25 mm
- At least 30% of subjects shall be male and at least 30% of subjects shall be female
You may not qualify if…
- 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 prescribed blood thinners.
- Subjects that cannot tolerate sitting for up to 1 hour.
- Subject with a blood pressure demographic that has already been filled
Where it is running
- Clinimark Laboratory Services — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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