PULSE OXIMETRYNCT07221526
SPO2 VALIDATION STUDY - PHILIPS FAST 2025
An observational study of PULSE OXIMETRY, run by Philips Clinical & Medical Affairs Global at 1 site in United States.
Trial summary
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology. 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
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2025to 5 Feb 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: The study population will include a minimum of 72 to approximately 90 healthy adult volunteers, divided into 2 test groups.
Who may be able to join
- Participants accepted into this study must meet all of 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, 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 (e.g. permanent, Henna) or artificial dyes (e.g. spray tan, artificial tanning lotion) 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
- 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 58Show fewer
- uncontrolled / severe asthma
- flu
- pneumonia / bronchitis
- shortness of breath / respiratory distress
- unresolved respiratory or lung surgery
- emphysema, COPD, lung disease
- recent COVID with hospitalization
- 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
- Participants with 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 (selfreported)
- 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.
- Unwillingness or inability to cut/trim fingernail(s) of test digits if determined length will interfere with correct application of the sensor
- Piercing at application site of the ear or nose sensors that may interfere with correct placement of sensor
- Participants received colored 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Element Materials Technology
Louisville, Colorado, 80027
About this study
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.
Read the detailed description
The primary objective of this clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology 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
- 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 |
|---|---|---|
| TEST GROUP 1 | Sensor Test Group 1
* AlarX4 (nasal ala placement)
* AlarX4 (earlobe placement)
* M1131AX1
* M1191BL - As Philips internal silver reference only Receives: Device: NO INTERVENTION | |
| TEST GROUP 2 | Sensor Test Group 2
* M1133AX5
* M1133AX6
* M1191BL - As Philips internal silver reference only Receives: Device: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPO2 ACCURACY
Accuracy expressed in Arms of SpO2 measurements obtained from the M1133AX5, M1133AX6, and AlarX4 (nasal ala placement) SpO2 sensors under test with the Philips Pulse Oximetry technology over the range of 70-100% SaO2 in comparison to SaO2 as ground truth.
Measured: OCTOBER 2025-JANUARY 2026
Secondary outcomes (3)
SPO2 ACCURACY
Accuracy expressed in Arms of SpO2 measurements obtained from the AlaxX4 SpO2 sensor (earlobe placement) with the Philips Pulse Oximetry technology over the range of 70-100% SaO2 in comparison to SaO2 as ground truth.
Measured: OCTOBER 2025-JANUARY 2026
DIFFERENTIAL MEAN
Maximum differential mean bias as developed by Philips for the M1133AX5, M1133AX6, AlarX4 (nasal ala application), and AlarX4 (earlobe application) in the SaO2 ranges of 70% ≤ SaO2 ≤ 85% and 85% < SaO2 ≤100%.
Measured: OCTOBER 2025-JANUARY 2026
PIGMENTATION DIFFERENTIAL BIAS
Pigmentation differential bias as proposed by ISO for the M1133AX5, M1133AX6, AlarX4 (nasal ala application), and AlarX4 (earlobe application) over the SaO2 range of 80-90%, centered at 85%.
Measured: OCTOBER 2025-JANUARY 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start28 Oct 2025
- Primary completion5 Feb 2026
- Study completion5 Feb 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 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 Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221526
- Sponsor's protocol ID
- CC-2025-301078-FAST 2025
- Status last verified
- Mar 2026
- First submitted
- 24 Oct 2025
- Last updated
- 1 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPO2 VALIDATION STUDY - PHILIPS FAST 2025
- ClinicalTrials.gov ID
- NCT07221526
- Acronym / sponsor ID
- CC-2025-301078-FAST 2025
- Conditions
- PULSE OXIMETRY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 5 Feb 2026 (actual)
- Study completion
- 5 Feb 2026 (actual)
- First posted
- 28 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.
Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.
Detailed description
The primary objective of this clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology 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
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST GROUP 1 | – | Device: NO INTERVENTIONSensor Test Group 1 * AlarX4 (nasal ala placement) * AlarX4 (earlobe placement) * M1131AX1 * M1191BL - As Philips internal silver reference only |
| TEST GROUP 2 | – | Device: NO INTERVENTIONSensor Test Group 2 * M1133AX5 * M1133AX6 * M1191BL - As Philips internal silver reference only |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population will include a minimum of 72 to approximately 90 healthy adult volunteers, divided into 2 test groups.
Key inclusion criteria (4 listed)
- Participants accepted into this study must meet all of 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
Key exclusion criteria (58 listed)
- Participant is considered as being morbidly obese (defined as BMI >39.5)
- Compromised circulation (i.e., Raynaud's Syndrome), injury, 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 (e.g. permanent, Henna) or artificial dyes (e.g. spray tan, artificial tanning lotion) 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
- 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 | TEST GROUP 1, TEST GROUP 2 |
Primary outcome
SPO2 ACCURACY
Time frame: OCTOBER 2025-JANUARY 2026
Accuracy expressed in Arms of SpO2 measurements obtained from the M1133AX5, M1133AX6, and AlarX4 (nasal ala placement) SpO2 sensors under test with the Philips Pulse Oximetry technology over the range of 70-100% SaO2 in comparison to SaO2 as ground truth.
3 secondary outcomes
SPO2 ACCURACY
Time frame: OCTOBER 2025-JANUARY 2026
DIFFERENTIAL MEAN
Time frame: OCTOBER 2025-JANUARY 2026
PIGMENTATION DIFFERENTIAL BIAS
Time frame: OCTOBER 2025-JANUARY 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 1 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for PULSE OXIMETRY
Recruiting
Temporal Dynamics of Peripheral SpO₂ During Reoxygenation
Healthy Vollunteer, Apnea
Recruiting
Transoral Nasal Cannula Oxygen Therapy for Mouth-Breathing Patients in the Postanesthesia Care Unit
Postoperative Hypoxemia
Not yet recruiting
Cohesive Bandage Fixation of Pulse Oximeter Probes and Skin Condition in Preterm Neonates
Skin Injury, Premature Birth
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
RecruitingObservational study
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Hypoxemia, Skin Pigment
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 Lab
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 4 inclusion and 58 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 1 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 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: OCTOBER 2025-JANUARY 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 1 Apr 2026.