Status:
COMPLETED
Comparison of Non-Invasive Blood Pressure Methods
Lead Sponsor:
Vital USA, Inc.
Collaborating Sponsors:
Clinimark, LLC
Conditions:
Blood Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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, dat...
Detailed Description
This study will include up to 100 adults ≥ 18 years of age. The final subject database will contain no fewer than 85 subjects with a minimum of 255 paired observations. At least 90% of the subjects wi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2020
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT04296227
Start Date
February 4 2020
End Date
March 3 2020
Last Update
May 13 2020
Active Locations (1)
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1
Clinimark Laboratory Services
Louisville, Colorado, United States, 80027