Status:
COMPLETED
Validation of Noninvasive Blood Pressure Device
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvas...
Eligibility Criteria
Inclusion
- Age 18 years and older
- Site 1; Stage 1 only: Subjects with a history of hypertension (\> 140/85 mmHg) or hypotension (\< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure
- Site 2; Stage 1 and 2: Subjects with systolic blood pressure \< 140/90 mmHg.
- Ability to provide informed consent
Exclusion
- Febrile subjects
- Subjects displaying respiratory symptoms, or with suspected respiratory illness
- Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site
- Subjects with removed axillary lymph nodes or mastectomies
- Subjects with peripheral artery disease
- Pregnant women (patient reported)
- Subjects deemed not suitable for the study at the discretion of the investigator
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2020
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04676152
Start Date
October 5 2020
End Date
November 2 2020
Last Update
January 8 2024
Active Locations (2)
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1
Site 2
Irvine, California, United States, 92618
2
Site 1
Lomita, California, United States, 90717