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

NCT07223177 | Recruiting FDA Device

• 1 other identifier: BERG0003
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 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

SpO2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The acceptability of the fit of sensor by visual observation of the emitter and detector alignment.

  45 minutes

Study Arms (1)

Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

EXPERIMENTAL

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

Interventions

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

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

Masimo Sensors (RD SET and/or LNCS) connected to Philips Monitors using Philips FAST SpO2 Algorithm

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (2)

Paradigm Clinical Research

Modesto, California, 95355, United States

RECRUITING

Paradigm Clinical Research

San Diego, California, 92108, United States

RECRUITING

Central Study Contacts

Chelsea Frank

CONTACT

949-297-7000; clinicalresearchdept@masimo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2025
• First Posted: October 31, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): June 5, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (2)