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

Masimo Corporation · NCT07223177

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 0 mo–21 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
100
US sites recruiting
2
Study start
December 17, 2025
Record last updated
July 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

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

Conditions: SpO2

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

  • 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.

Recruiting US locations

  • Paradigm Clinical Research

    Modesto, CA 95355

    Site contact: Chelsea Frank · 949-297-7000

  • Paradigm Clinical Research

    San Diego, CA 92108

    Site contact: Chelsea Frank · 949-297-7000

Study contacts (from the official record)

  • Chelsea Frank · 949-297-7000 · clinicalresearchdept@masimo.com
All healthy volunteers studies in California →
Philips FAST SpO2 Technology With Masimo Sensors for SpO2… (NCT07223177) | Bored Studies