Actively Recruiting
Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
Led by Masimo Corporation · Updated on 2026-03-04
100
Participants Needed
2
Research Sites
24 weeks
Total Duration
On this page
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Subject has a skin condition or deformity at the planned sensor application site preventing sensor placement (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown).
- Confounders of pulse oximetry per sensor direction for use.
- Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo) where the sensor is applied.
- Subject has absence or deformities of limbs or severe edema interfering with sensor application or proper fit.
- Subject with nail polish or acrylic nails on digits where sensor needs to be applied who refuses removal.
- Subject with known allergic reactions to adhesive tapes.
- Subject deemed unsuitable for investigation by the clinical research team.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Paradigm Clinical Research
Modesto, California, United States, 95355
Actively Recruiting
2
Paradigm Clinical Research
San Diego, California, United States, 92108
Actively Recruiting
Research Team
C
Chelsea Frank
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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