NCT07221526

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 28, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

October 28, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

October 24, 2025

Last Update Submit

March 31, 2026

Conditions

PULSE OXIMETRY

Outcome Measures

Primary Outcomes (1)

  • 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.

    OCTOBER 2025-JANUARY 2026

Secondary Outcomes (3)

  • SPO2 ACCURACY

    OCTOBER 2025-JANUARY 2026

  • DIFFERENTIAL MEAN

    OCTOBER 2025-JANUARY 2026

  • PIGMENTATION DIFFERENTIAL BIAS

    OCTOBER 2025-JANUARY 2026

Study Arms (2)

TEST GROUP 1

Sensor Test Group 1 * AlarX4 (nasal ala placement) * AlarX4 (earlobe placement) * M1131AX1 * M1191BL - As Philips internal silver reference only

Device: NO INTERVENTION

TEST GROUP 2

Sensor Test Group 2 * M1133AX5 * M1133AX6 * M1191BL - As Philips internal silver reference only

Device: NO INTERVENTION

Interventions

NO INTERVENTIONDEVICE

NO INTERVENTION

TEST GROUP 1TEST GROUP 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will include a minimum of 72 to approximately 90 healthy adult volunteers, divided into 2 test groups.

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • 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)
  • +43 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

Location

Study Officials

  • Monica Rabanal, NP

    Element Desaturation Lab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2025

First Posted

October 28, 2025

Study Start

October 28, 2025

Primary Completion

February 5, 2026

Study Completion

February 5, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)