Blood Pressure MeasurementiNIBPNCT07901608
Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
An observational study of Blood Pressure Measurement, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 3 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure Measurement
- What is being tested?
- Blood Pressure Measurement
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population will include a minimum of 85 to 150, pediatric and adult volunteers.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Element Materials Technology
Louisville, Colorado, 80027
Monica Rabanal, NP, 303-926-5432, monica.rabanal@element.com
Monica Rabanal, NP
About this study
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.
- Conditions
- Blood Pressure Measurement
- Being tested
- Blood Pressure Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Pressure MeasurementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants will be 3 to 85 years of age with an upper arm circumference within 14 - 43 cm. | Not described Receives: Other: Blood Pressure Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Oct 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Pressure MeasurementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901608
- Sponsor's protocol ID
- SEF-2026-302093
- Acronym
- iNIBP
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philips Inflationary-Based Non-Invasive Blood Pressure Validation Study
- ClinicalTrials.gov ID
- NCT07901608
- Acronym / sponsor ID
- iNIBP / SEF-2026-302093
- Conditions
- Blood Pressure Measurement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants will be 3 to 85 years of age with an upper arm circumference within 14 - 43 cm. | – | Other: Blood Pressure Measurement |
Who may qualify
- Ages
- 3 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will include a minimum of 85 to 150, pediatric and adult volunteers.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Pressure MeasurementThe 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. | Other | Participants will be 3 to 85 years of age with an upper arm circumference within 14 - 43 cm. |
Primary outcome
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
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure Measurement, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Rodriguez (857-275-9668, Jessica.Rodriguez_1@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.