Fresenius Noninvasive Blood Pressure Validation
Completed · Not applicable
Conditions studied: Blood Pressure
In brief
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.
Key facts
- Study ID
- NCT04573595
- Run by
- Fresenius Medical Care North America
- People needed
- 159
- Starts
- 2020-09-17
- Expected to finish
- 2020-12-04
- Last updated by the study team
- 2021-02-02
Who can join
Age: 13 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.
- Subjects must be ≥ 13 years of age for Phase 1.
- Subjects must be ≥ 3 years of age for Phase 2 and 3.
- 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.
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 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, Site ID#001 — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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