Status:
RECRUITING
Philips FAST SpO2 Technology With Masimo Sensors for SpO2 Monitoring in the Neonatal, Infant, and Pediatric Populations
Lead Sponsor:
Masimo Corporation
Conditions:
SpO2
Eligibility:
All Genders
Up to 21 years
Phase:
NA
Brief 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 po...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 5 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07223177
Start Date
December 17 2025
End Date
June 5 2026
Last Update
January 7 2026
Active Locations (2)
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1
Paradigm Clinical Research
Modesto, California, United States, 95355
2
Paradigm Clinical Research
San Diego, California, United States, 92108