NEXT GEN - PHILIPS OPTIMUS

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.

Study Overview

• Status: Recruiting
• Conditions: Pulse Oximetry
• Intervention / Treatment: Device: Philips MR400 Pro MRI Patient Monitor

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 Type: Observational
• Enrollment (Estimated): 36

Contacts and Locations

• Study Contact: Name: Dominque Watson; Phone Number: 724-334-3117; Email: dominque.watson@philips.com
• Study Contact Backup: Name: Vanessa Assibey-Mensah; Phone Number: 724-334-3117; Email: vanessa.assibey-mensah@philips.com

Study Locations

• United States
  • Colorado
    • Louisville, Colorado, United States, 80027
      • Recruiting
      • Element Materials Technology
      • Contact: Monica Rabanal, NP; Email: monica.rabanal@element.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion 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.
• Male or female assigned at birth of any race.

Exclusion Criteria:

• 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)

  • 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Philips MR400 Pro MRI Patient Monitor; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%).	March-April 2026

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	March-April 2026

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): April 3, 2026
• Study Completion (Estimated): April 3, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SEF 2025-301543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes