Pulse OximetryNCT07521735
NEXT GEN - PHILIPS OPTIMUS
An observational study of Pulse Oximetry, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
The purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulse Oximetry
- What is being tested?
- Philips MR400 Pro MRI Patient Monitor
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: At least 36 participants considered healthy, non-smoking (or have refrained from smoking for 2 days) competent adults, ages 18 to 50 years.
Who may be able to join
- Participant must have the ability to understand and provide written informed consent.
- Participant is an adult between 18-50 years of age.
- Participant must be willing and able to comply with study procedures and duration.
- Participant is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female assigned at birth of any race.
Who cannot join
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Females who are pregnant
- Females who are trying to get pregnant (with confirmation of positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
- Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
- Participants with known respiratory conditions such as: (self-reported)
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- uncontrolled / severe asthma,
- flu,
- pneumonia / bronchitis,
- shortness of breath / respiratory distress,
- unresolved respiratory or lung surgery,
- emphysema, COPD, lung disease
- Recent COVID with or without hospitalization (last 2 months)
- Participants with self-reported heart or cardiovascular conditions such as: (self-reported, except for blood pressure and ECG review)
- high blood pressure: systolic >140 mmHg or diastolic >90 mmHg on 3 consecutive readings (reviewed during health screen)
- have had cardiovascular surgery, except successful minor surgery without clinical symptoms (i.e., PFO, PDA)
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke
- transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- implantable active medical device such as pacemaker or automatic defibrillator
- Self-reported health conditions as identified in the Health Assessment Form
- diabetes,
- uncontrolled thyroid disease,
- kidney disease / chronic renal impairment,
- history of seizures (except childhood febrile seizures),
- epilepsy,
- history of unexplained syncope,
- recent history of frequent migraine headaches,
- recent symptomatic head injury (within the last 2 months),
- Cancer requiring chemotherapy, radiation, or current treatment.
- Participants with known clotting disorders (self-reported)
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- current use of blood thinner: prescription or daily use of aspirin
- Sickle Cell Trait or Disease
- Participants with self-reported dermatological conditions at sensor application sites
- severe dermatitis
- hyperkeratosis
- nail fungus
- Participants with severe contact allergies to standard adhesives, latex, silicone or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors (self-reported)
- Participants with severe allergies to iodine (only applicable if iodine is used)
- Participants with severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocaine)
- Participants with allergies to ultrasound gel
- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio <0.4)
- Unwillingness or inability to remove nail polish, nail jewelry, or artificial nails from test digits. Bruised nail bed of test digits (Note: Certain bruising may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Unwillingness or inability to cut/trim fingernail(s) of test digits if determined length will interfere with correct application of the sensor.
- Participant received intravascular dye within the past 48 hours (e.g. Indocyanine green, methylene blue, indiocarmine, dyes used in cardiac output monitoring)
- Surgical hardware in pathway of Device Under Test
- Other known health conditions should be considered upon disclosure in health assessment form.
- Participants with uneven skin tone at the sensor site or at the forehead
- Participants who were previously enrolled and/or included in the terminated Optimus Validation study
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
Official title: SPO2 NEXT GEN VALIDATION STUDY - PHILIPS OPTIMUS
The purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
Read the detailed description
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.
- Conditions
- Pulse Oximetry
- Being tested
- Philips MR400 Pro MRI Patient Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips MR400 Pro MRI Patient MonitorDevice
Philips IntelliVue Patient Monitor X3 Philips Adult SpO2 Sensor (M1191BL) Philips Wireless Patient Module SpO2 (Gen-4) SpO2 Sensor, MRI (Gen-4) Adult SpO2 Glove Adult SpO2 Grips
| Study group | Role | What they receive |
|---|---|---|
| Study Population - 18 to 50 Years | The study population will include a minimum of 36 participants up to a maximum of 72, healthy male and female volunteers of any race, ranging in pigmentation from light to dark. Receives: Device: Philips MR400 Pro MRI Patient Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 accuracy
SpO2 accuracy will be evaluated for root-mean-square (rms) difference between the DUT and the reference for the specified SpO2 ranges (70-100%) and by SaO2 decade (90-100%, 80<90%, 70-<80%).
Measured: March-April 2026
Secondary outcomes (1)
Assess Pigmentation
To assess pigmentation differential bias of the SpO2 sensors under non-motion conditions using the Philips MRI Patient Monitoring Pulse Oximetry Subsystem, in accordance with Philips and ISO methods.
Measured: March-April 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start9 Mar 2026
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse OximetryStudies 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
- 46 participants (actual)
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
- NCT07521735
- Sponsor's protocol ID
- SEF 2025-301543
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPO2 NEXT GEN VALIDATION STUDY - PHILIPS OPTIMUS
- ClinicalTrials.gov ID
- NCT07521735
- Acronym / sponsor ID
- SEF 2025-301543
- Conditions
- Pulse Oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 13 Apr 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 purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.
Detailed description
To validate the SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions over the range of 70-100% SaO2, when compared with the reference SaO2 obtained from CO-Oximetry analysis of arterial blood samples.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population - 18 to 50 Years | – | Device: Philips MR400 Pro MRI Patient MonitorThe study population will include a minimum of 36 participants up to a maximum of 72, healthy male and female volunteers of any race, ranging in pigmentation from light to dark. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- At least 36 participants considered healthy, non-smoking (or have refrained from smoking for 2 days) competent adults, ages 18 to 50 years.
Key inclusion criteria (5 listed)
- Participant must have the ability to understand and provide written informed consent.
- Participant is an adult between 18-50 years of age.
- Participant must be willing and able to comply with study procedures and duration.
- Participant is a non-smoker or who has not smoked within 2 days prior to the study.
- Male or female assigned at birth of any race.
Key exclusion criteria (61 listed)
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
- Females who are pregnant
- Females who are trying to get pregnant (with confirmation of positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
- Participants who have smoked in the last 2 days or participants who have refrained, for at least 48 hours, with COHb levels >3% as assessed with a Masimo Radical 7 (Rainbow)
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 |
|---|---|---|
| Philips MR400 Pro MRI Patient MonitorPhilips IntelliVue Patient Monitor X3 Philips Adult SpO2 Sensor (M1191BL) Philips Wireless Patient Module SpO2 (Gen-4) SpO2 Sensor, MRI (Gen-4) Adult SpO2 Glove Adult SpO2 Grips | Device | Study Population - 18 to 50 Years |
Primary outcome
SpO2 accuracy
Time frame: March-April 2026
SpO2 accuracy will be evaluated for root-mean-square (rms) difference between the DUT and the reference for the specified SpO2 ranges (70-100%) and by SaO2 decade (90-100%, 80<90%, 70-<80%).
1 secondary outcome
Assess Pigmentation
Time frame: March-April 2026
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulse Oximetry, 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 5 inclusion and 61 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: finished, as of the sponsor's last update on 15 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2 accuracy (time frame: March-April 2026). 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 15 Jul 2026.