Status:
COMPLETED
Philips Non-Invasive Blood Pressure Validation Study of VS30 Monitor
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Collaborating Sponsors:
Element Materials Technology
Conditions:
Non Invasive Blood Pressure
Eligibility:
All Genders
3-85 years
Brief Summary
The purpose of this study is to provide supporting documentation of the blood pressure performance for the Philips EarlyVue VS30 monitor on the intended adult and pediatric population. The same arm se...
Detailed Description
The Philips EarlyVue VS30 monitor, and approved Philips Gentle Care cuffs will be evaluated in comparison to dual reference auscultation. The study will consist of a minimum of 85 participants, specif...
Eligibility Criteria
Inclusion
- Participants must be able to provide an informed consent or have legally authorized representative consent to participate.
- Participants that are between 7 and 17 years of age must provide assent to participate in the study.
- Participant must be willing and able to comply with the study procedures.
- Participant or legally authorized representative must be able to read or write in English.
- Participant must be 3 to 85 years of age.
- Participants must have an arm circumference in the range of 14-45 centimeters.
Exclusion
- Participant is unwilling to provide informed consent.
- Participants with deformities or abnormalities that may prevent proper application of the device under test.
- Participants whose upper arm circumference is less than 14 cm or greater than 45 cm.
- Female participants who are self-reported as pregnant, or who are self-reported as trying to get pregnant.
- Participants with known heart arrhythmias.
- Participants with peripheral vascular disease.
- Participants with clotting disorders.
- History of bleeding disorders or personal history of prolonged bleeding from injury
- History of blood clots
- Hemophilia
- Participants that cannot tolerate sitting for up to 1 hour.
- Participant with a blood pressure demographic that has already been filled.
- Other known health conditions that will prevent safe participation in the study upon disclosure in health assessment form or verbally.
- Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
Key Trial Info
Start Date :
March 10 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06980766
Start Date
March 10 2025
End Date
March 31 2025
Last Update
December 9 2025
Active Locations (1)
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1
Element Materials Technology
Louisville, Colorado, United States, 80027