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

Recruiting now · Not applicable

Conditions studied: SpO2

In brief

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.

Key facts

Study ID

NCT07223177

Run by

Masimo Corporation

People needed

100

Starts

2025-12-17

Expected to finish

2026-12-31

Last updated by the study team

2026-07-13

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Paradigm Clinical Research — Modesto, California, United States (enrolling)
• Paradigm Clinical Research — San Diego, California, United States (enrolling)

Full record on ClinicalTrials.gov

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