Pulse Oximetry, Oxygen Measurements, SpO2NCT07215429
SpO2 Validation Study-Philips Optimus
An observational study of Pulse Oximetry, Oxygen Measurements, SpO2, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
Validation study 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, Oxygen Measurements, SpO2
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2025to 19 Sep 2025
- 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: minimum of 66 participants up to a maximum of 180, healthy male and female volunteers of any race, ranging in pigmentation from light to dark. he study population will meet the following stratification criteria: * At least 25% of the population with Monk 1-3 with ITA > 30 at the forehead * At least 25% of the population with Monk 4-7 with ITA ≤ 30 and ≥ -30 at the forehead * At least 25% of the population with Monk 8-10 with ITA < -30 at the forehead * At least half of the participants in this group will have an ITA < -50 at the forehead * In the event the Monk and ITA place a participant in different cohorts, the ITA shall be used to determine the demographic cohort for the participant * At least 40% of the population male * At least 40% of the population female
Who may be able to join
- Participants accepted in this study must meet all the following criteria:
- 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.
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)
Show all 54Show fewer
- 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 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),
- Failure of the Perfusion Index Ulnar/Ulnar+Radial Ratio test (Ratio <0.4)
- Unwillingness or inability to remove nail polish or artificial nails from test digits.
- Participant received intravascular dye within the past 48 hours (e.g. Indocyanine green, methylene blue, 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
Official title: SpO2 Validation Study - Philips Optimus
Validation study 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
The intent 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. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the Sponsor's pulse oximeter with consideration to anticipated updates to ISO 80601-2-61:2025(E)
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDevice
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Philips Wireless Patient Module SpO2 (Gen-4) | This device is a complete pulse oximeter measurement module that utilizes the Philips PicoSAT II+ SpO2 processor that is a component on the circuit car assembly, part number 453665151651. This processor incorporates all signal processing and algorithms to derive the oxygen saturation value (SpO2), pulse rate, perfusion indicator value, and the plethysmographic waveform Receives: Device: No intervention | |
| SpO2 Sensor, MRI (Gen-4) | This is a fiber-optic cable that is attached via an connector at one end to the Philips Wireless SpO2 Patient Module, and one of the SpO2 finger accessories at the other end. This cable serves as the conduit through which red and infrared light is transmitted into the finger and then is received back from the other side of the finger into the photodiode. The red and infrared LEDs and the photodiode are all contained in the cable housing. The cable itself is made from RoHS-compliant fiber-optic materials. Fiber-optics are utilized to allow the SpO2 module to operate properly in the MRI environment. Receives: Device: No intervention | |
| SpO2 Accessories: SpO2 Grips (Single Use) and SpO2 Gloves (Reusable) | The SpO2 Grips and Gloves are designed to securely hold the SpO2 Sensor in proper location when it is attached to the Wireless SpO2 module. Both finger accessories provide two slide-in clip attachments for connecting to the SpO2 Cable ends, designed to be positioned at the top and bottom of the finger. The reusable finger accessory is designed to slide onto the finger and secure itself by means of a rubber-like material that provides the appropriate grip Receives: Device: No intervention | |
| Silver Reference: IntelliVue Patient Monitor X3 and Adult SpO2 Sensor (M1191BL) | The IntelliVue X3 is a versatile patient monitoring device with a color touchscreen display. It can simultaneously monitor ECG (using 3-, 5-, 6- or 10-lead sets, including arrhythmia and ST monitoring), respiration, SpO2, NBP, two invasive pressures, temperature, and CO2. The multi-touch screen allows easy interaction by swiping and tapping with one or two fingers. Receives: Device: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
evaluate non-disparate performance (differential bias) of the SpO2 sensors under test
with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% < SaO2 ≤100%.
with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% < SaO2 ≤100%.
with the Philips MRI Patient Monitoring Pulse Oximetry Subsystem during non-motion conditions in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% < SaO2 ≤100%.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start9 Sep 2025
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
Why it stopped: The clinical study was terminated ahead of schedule due to the availability of next-generation devices.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulse Oximetry, Oxygen Measurements, SpO2Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Monica Rabanal, NP, Principal investigator, Element Desaturation Labratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215429
- Sponsor's protocol ID
- Protocol # PR 2024-608_300178
- Status last verified
- Apr 2026
- First submitted
- 8 Sep 2025
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Validation Study - Philips Optimus
- ClinicalTrials.gov ID
- NCT07215429
- Acronym / sponsor ID
- Protocol # PR 2024-608_300178
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The clinical study was terminated ahead of schedule due to the availability of next-generation devices.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 10 Oct 2025 (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.
Validation study 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
The intent 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. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the Sponsor's pulse oximeter with consideration to anticipated updates to ISO 80601-2-61:2025(E)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Philips Wireless Patient Module SpO2 (Gen-4) | – | Device: No interventionThis device is a complete pulse oximeter measurement module that utilizes the Philips PicoSAT II+ SpO2 processor that is a component on the circuit car assembly, part number 453665151651. This processor incorporates all signal processing and algorithms to derive the oxygen saturation value (SpO2), pulse rate, perfusion indicator value, and the plethysmographic waveform |
| SpO2 Sensor, MRI (Gen-4) | – | Device: No interventionThis is a fiber-optic cable that is attached via an connector at one end to the Philips Wireless SpO2 Patient Module, and one of the SpO2 finger accessories at the other end. This cable serves as the conduit through which red and infrared light is transmitted into the finger and then is received back from the other side of the finger into the photodiode. The red and infrared LEDs and the photodiode are all contained in the cable housing. The cable itself is made from RoHS-compliant fiber-optic materials. Fiber-optics are utilized to allow the SpO2 module to operate properly in the MRI environment. |
| SpO2 Accessories: SpO2 Grips (Single Use) and SpO2 Gloves (Reusable) | – | Device: No interventionThe SpO2 Grips and Gloves are designed to securely hold the SpO2 Sensor in proper location when it is attached to the Wireless SpO2 module. Both finger accessories provide two slide-in clip attachments for connecting to the SpO2 Cable ends, designed to be positioned at the top and bottom of the finger. The reusable finger accessory is designed to slide onto the finger and secure itself by means of a rubber-like material that provides the appropriate grip |
| Silver Reference: IntelliVue Patient Monitor X3 and Adult SpO2 Sensor (M1191BL) | – | Device: No interventionThe IntelliVue X3 is a versatile patient monitoring device with a color touchscreen display. It can simultaneously monitor ECG (using 3-, 5-, 6- or 10-lead sets, including arrhythmia and ST monitoring), respiration, SpO2, NBP, two invasive pressures, temperature, and CO2. The multi-touch screen allows easy interaction by swiping and tapping with one or two fingers. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- minimum of 66 participants up to a maximum of 180, healthy male and female volunteers of any race, ranging in pigmentation from light to dark. he study population will meet the following stratification criteria: * At least 25% of the population with Monk 1-3 with ITA > 30 at the forehead * At least 25% of the population with Monk 4-7 with ITA ≤ 30 and ≥ -30 at the forehead * At least 25% of the population with Monk 8-10 with ITA < -30 at the forehead * At least half of the participants in this group will have an ITA < -50 at the forehead * In the event the Monk and ITA place a participant in different cohorts, the ITA shall be used to determine the demographic cohort for the participant * At least 40% of the population male * At least 40% of the population female
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.
Key exclusion criteria (54 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 |
|---|---|---|
| No interventionNo intervention | Device | Philips Wireless Patient Module SpO2 (Gen-4), Silver Reference: IntelliVue Patient Monitor X3 and Adult SpO2 Sensor (M1191BL), SpO2 Accessories: SpO2 Grips (Single Use) and SpO2 Gloves (Reusable), SpO2 Sensor, MRI (Gen-4) |
Primary outcome
SpO2 accuracy of the SpO2 sensors under test with the Philips MRI Patient Monitoring
Time frame: Day 1
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.
1 secondary outcome
evaluate non-disparate performance (differential bias) of the SpO2 sensors under test
Time frame: Day 1
Results and safety
The study was stopped early (reason given: The clinical study was terminated ahead of schedule due to the availability of next-generation devices.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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.
Monica Rabanal, NP principal investigator
Element Desaturation Labratory
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, Oxygen Measurements, SpO2, 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 54 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: stopped early, as of the sponsor's last update on 13 Apr 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 was stopped early (reason given: The clinical study was terminated ahead of schedule due to the availability of next-generation devices.). Results are not available in the source record.
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 of the SpO2 sensors under test with the Philips MRI Patient Monitoring (time frame: Day 1). 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 13 Apr 2026.