Recruiting

Blood Pressure Measurement

Sponsor:

Philips Clinical & Medical Affairs Global

Code:

NCT07901608

Conditions

Blood Pressure Measurement

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Accepted

Interventions

Blood Pressure Measurement

Study Details

Brief 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.

Conditions

Blood Pressure Measurement

Study ID

NCT07901608

Start date

Oct 15, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Participants must be 3 to 85 years of age.
  • Participants, parents or legal guardians of participants must be able to provide informed consent, 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:

  • Participant, parent or legal guardian of participant is unwilling to provide informed consent, 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.

Study Design

Enrollment

85 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Blood 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.

Primary outcome measure

  • Compare blood measurements obtained from the Philips Inflationary-based non-invasive blood pressure (iNIBP) system to the accepted auscultatory reference method. [ Time Frame: Up to 8 weeks ]

Central Contacts and Locations

Central contacts

Jessica Rodriguez

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

Locations

Element Materials Technology

Recruiting

Louisville, Colorado, United States, 80027

Contacts

Monica Rabanal, NP

303-926-5432monica.rabanal@element.com

Principal Investigator:

Monica Rabanal, NP

More Information

Sponsor

Philips Clinical & Medical Affairs Global

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Philips Clinical & Medical Affairs Global on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.