Philips Non-Invasive Blood Pressure Validation Study

Stopped early

Conditions studied: Non Invasive Blood Pressure

In brief

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 sequential method with dual observer auscultation will be used to collect data.

Key facts

Study ID

NCT06682312

Run by

Philips Clinical & Medical Affairs Global

People needed

89

Starts

2024-10-14

Expected to finish

2024-10-23

Last updated by the study team

2024-11-12

Who can join

Age: 3 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Element Materials Technology — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

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