Philips Non-Invasive Blood Pressure Validation Study

NCT06682312 | Terminated FDA Device

• 1 other identifier: PR 2024-601
• Study Type: observational
• Target: 89
• 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

Keywords

NIBP; Blood pressure; Spotcheck

Outcome Measures

Primary Outcomes (1)

• Validation of earlyvue VS30 Monitor

  The primary objective of this study is to provide a validation following ISO 81060-2:2018/AMD 2:2024 for noninvasive blood pressure measurement accuracy for the Philips EarlyVue VS30 on the intended population. The EarlyVue VS30 will be compared to the reference sphygmomanometer via same arm sequential method with dual auscultators. The end goal is to pass the Criterion 1 and Criterion 2 of ISO 81060-2:2018/AMD 2:2024 Criterion 1 * Mean Error of individual paired determinations ≤ ±5.0 mmHg * Standard Deviation of determination ≤ 8.0mmHg Criterion 2 • Standard Deviation of the average paired determinations must meet the maximum permissible standard deviation in Table 1 - Averaged subject data acceptance (criterion 2) in mmHg per the standard

  2 weeks

Study Arms (2)

Pediatrics

Participants aged 3-12 years

Device: Non-invasive blood pressure

Adults

Participants aged 12-85 years

Interventions

Non-invasive blood pressure DEVICE

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

Pediatrics

Eligibility Criteria

• Age: 3 Years - 85 Years
• Gender Eligibility Details: Males and Females
• 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

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

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Study Design

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

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: October 14, 2024
• Primary Completion: October 23, 2024
• Study Completion: October 23, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)