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

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.

Study Overview

• Status: Recruiting
• Conditions: SpO2
• Intervention / Treatment: Device: Masimo Sensor (RD SET and/or LNCS) connected to Philips Monitor using Philips FAST SpO2 Algorithm

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chelsea Frank; Phone Number: 949-297-7000; Email: clinicalresearchdept@masimo.com

Study Locations

• United States
  • California
    • Modesto, California, United States, 95355
      • Recruiting
      • Paradigm Clinical Research
      • Contact: Chelsea Frank; Phone Number: 949-297-7000
    • San Diego, California, United States, 92108
      • Recruiting
      • Paradigm Clinical Research
      • Contact: Chelsea Frank; Phone Number: 949-297-7000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	45 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
The acceptability of the fit of sensor by visual observation of the emitter and detector alignment.	45 minutes

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026

Study Registration Dates

• First Submitted: October 29, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): October 31, 2025

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: BERG0003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes