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RecruitingNCT07223177Updated Jul 13, 2026

Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations

An interventional study of Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm in SpO2, sponsored by Masimo Corporation. Recruiting at 2 sites in United States. Open to participants aged 0 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Masimo Corporation (part of Danaher Corporation) · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
0 Years to 21 Years
Sex
All
01

Study summary

The objective of this study is to verify the form, fit and function of the Philips FAST technology with Masimo neonatal, infant and pediatric sensors for SpO2 monitoring in the respective indicated populations. The study design uses convenience sample data collection from neonatal, infant, and pediatric sensors within their respective indicated patient populations that have a range of different skin pigmentations, simultaneously with an FDA cleared pulse oximeter as a comparator.

02

Conditions studied

  • SpO2
03

In context

Lead sponsor

Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.

First submitted before Masimo Corporation became part of Danaher Corporation.

Browse Masimo Corporation studies →All Danaher Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor.
  • Subject is less than 22 years of age (pediatric subject per US FDA definition).

Exclusion criteria

Exclusion Criteria:

  • Subject has a skin condition or deformity at the planned sensor application site, which would preclude sensor placement and measurements as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown).
  • Confounders of pulse oximetry per sensor direction for use (DFU).
  • Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied.
  • Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
  • Subject with nail polish or acrylic nails on the digits where sensor needs to be applied, who opts to not remove it.
  • Subject with known allergic reactions to adhesive tapes.
  • Subject is not suitable for the investigation at the discretion of the clinical research team.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

    All subjects are enrolled into this arm. All subjects will have blood oxygen measurements from: * non-invasive Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm for blood oxygen measurements and * Masimo RD SET sensors connected to FDA-cleared pulse oximeter

    Device: Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm

Interventions

  • DeviceMasimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm

    Subjects may use multiple Masimo sensors (RD SET and/or LNCS). All subjects will have at least one Masimo sensor (RD SET or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

06

What researchers measure

Primary outcomes

  1. The acceptability of the quality of SpO2 signal obtained during non-invasive oxygen saturation monitoring using Philips FAST SpO2 technology with Masimo neonatal, infant, and pediatric sensors. Accuracy root mean square (ARMS) will be calculated.

    Time frame: 45 minutes

Secondary outcomes

  1. The acceptability of the fit of sensor by visual observation of the emitter and detector alignment.

    Time frame: 45 minutes

07

Study locations

2 of 2 sites recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07223177
Lead sponsor
Masimo Corporation
Responsible party
Sponsor
First posted
Oct 31, 2025
Start date
Dec 17, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 13, 2026

Study contacts

Chelsea Frank
Contact
clinicalresearchdept@masimo.com
949-297-7000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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