Philips Non-Invasive Blood Pressure Validation Study of VS30 Monitor

NCT06980766 | Completed FDA Device

• 1 other identifier: PR2024-610_CC-2024-300840
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 1

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

Conditions

Non Invasive Blood Pressure

Outcome Measures

Primary Outcomes (1)

• primary objective of this study is to provide a validation following ISO (International Organization for Standardization )81060-2:2018/AMD (Amendment) 2:2024

  Noninvasive blood pressure measurement accuracy for the Philips EarlyVue VS30 on the intended population in comparison to the reference sphygmomanometer via same arm sequential method with dual auscultators

  2-4 weeks

Study Arms (2)

Pediatrics Participants aged 3-12 years

Device: Non-invasive blood pressure Manual blood pressure via sphygmomanometer Or Non invasive blood pressure via EarlyVue VS30 Monitor

Device: Non Invasive Blood Pressure

Adults Participants aged 12-85 years

Device: Non-invasive blood pressure Manual blood pressure via sphygmomanometer Or Non invasive blood pressure via EarlyVue VS30 Monitor

Device: Non Invasive Blood Pressure

Interventions

Non Invasive Blood Pressure DEVICE

Manual blood pressure via sphygmomanometer Or Non invasive blood pressure via earlyvue VS30 Monitor

Adults Participants aged 12-85 years; Pediatrics Participants aged 3-12 years

Eligibility Criteria

• Age: 3 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers, both male and females aged 3-85. Minimum of 35 participants aged 3-12 and a minimum of 50 participants aged \>12-85

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.

Sponsors & Collaborators

• Element Materials Technology: collaborator
• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Study Officials

• Monica Rabanal, NP

  Element

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: March 10, 2025
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)