ClinicalTrials.gg
RecruitingNCT07901608iNIBPUpdated Oct 28, 2026

Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study

An observational study in Blood Pressure Measurement, sponsored by Philips Clinical & Medical Affairs Global. Recruiting at 1 site in United States. Open to participants aged 3 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Observational

Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
85
Ages
3 Years to 85 Years
Sex
All
01

Study summary

The main purpose of this study is to assess the equivalence between blood pressure measurements obtained using the Philips iNIBP system and those determined by the auscultatory reference method.

Read the detailed description

The main purpose of the study is to determine the equivalence in the mean difference (bias) and standard deviation (SD) between inflationary based non-invasive blood pressure (iNIBP) measurements (systolic blood pressure, diastolic blood pressure, mean arterial pressure) and reference auscultatory BP measurements, assessed using a same-arm sequential measurement method with dual independent observers.

02

Conditions studied

  • Blood Pressure Measurement
03

In context

Lead sponsor

Philips Clinical & Medical Affairs Global is the lead sponsor of 85 studies on the registry; 25 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 12 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will include a minimum of 85 to 150, pediatric and adult volunteers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants must be 3 to 85 years of age.
  • Participants, parents or legal guardians of participants must be able to provide , parental permission, and/or assent form.
  • Participants that are between 7 and 17 (inclusive) years of age must provide assent to participate in the study.
  • Participants, parents or legal guardians of participants must be able to read or write in English and participants that are between the age of 7-17 must be able to understand English to provide assent.
  • Participant must be willing and able to comply with study procedures and duration.
  • Participants must have an upper arm circumference in the range of 14-43 centimeters.

Exclusion criteria

Exclusion Criteria:

  • Participant, parent or legal guardian of participant is unwilling to provide , parental permission, and/or assent.
  • Participants with deformities or abnormalities that may prevent proper application of the device under test.
  • Participants with an upper arm circumference less than 14 cm or greater than 43 cm.
  • Female participants who are pregnant.
  • Female participants who are trying to get pregnant with confirmation of positive urine pregnancy test.
  • 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 1-2 hours.
  • Participant with a blood pressure or other demographics that have already been filled.
  • Other known health conditions that will prevent safe participation in the study upon disclosure in screening form or verbally.
  • Participant is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study.
  • Participants where the Korotkoff sounds (fifth phase (K5)) for determining DBP is not audible.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
85 participants (estimated)
Patient registry
No

Groups and cohorts

  • Participants will be 3 to 85 years of age with an upper arm circumference within 14 - 43 cm.

    Other: Blood Pressure Measurement

Interventions

  • OtherBlood Pressure Measurement

    The Philips inflationary based algorithm of the IntelliVue X3 Monitor will be used to measure systolic blood pressure, diastolic blood pressure, and mean arterial pressure compared to the ausculatory reference method.

06

What researchers measure

Primary outcomes

  1. Compare blood measurements obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the accepted auscultatory reference method.

    Compare blood measurements (systolic blood pressure, diastolic blood pressure, and mean arterial pressure) obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the accepted auscultatory reference method.

    Time frame: Up to 8 weeks

Secondary outcomes

  1. Compare the pulse rate obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the pulse rate obtained from a refence PPG obtained from a pulse oximetry sensor.

    Compare the pulse rate obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the pulse rate obtained from a refence PPG obtained from a pulse oximetry sensor.

    Time frame: Up to 8 weeks

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07901608
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Oct 15, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 28, 2026

Study contacts

Jessica Rodriguez
Contact
Jessica.Rodriguez_1@philips.com
857-275-9668

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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