NCT07521735

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

March 9, 2026

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

March 31, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

25 days

First QC Date

March 31, 2026

Last Update Submit

April 7, 2026

Conditions

Pulse Oximetry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Assess Pigmentation

    March-April 2026

Study Arms (1)

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

Interventions

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 Population - 18 to 50 Years

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

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, 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)
  • +46 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Element Materials Technology

Louisville, Colorado, 80027, United States

RECRUITING

Central Study Contacts

Dominque Watson

CONTACT

724-334-3117dominque.watson@philips.com

Vanessa Assibey-Mensah

CONTACT

724-334-3117vanessa.assibey-mensah@philips.com

Study Design

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

Study Record Dates

First Submitted

March 31, 2026

First Posted

April 13, 2026

Study Start

March 9, 2026

Primary Completion

April 3, 2026

Study Completion

April 3, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)