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

Part of paid clinical trials in Modesto, California.

Sponsor
Masimo Corporation
Study ID
NCT07223177
Status
Recruiting
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Conditions

  • SpO2

Eligibility Criteria

Sex
ALL
Age
0 Years - 21 Years
Healthy Volunteers
Accepted

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

Study Details

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 Dates

Start date
Dec 17, 2025
Status verified
Mar 2026
Primary completion
Jun 5, 2026
Completion
Jun 5, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • 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

Primary Outcome Measure

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. [ Time Frame: 45 minutes ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Paradigm Clinical ResearchModestoCalifornia95355
Chelsea Frank
949-297-7000
Paradigm Clinical ResearchSan DiegoCalifornia92108
Chelsea Frank
949-297-7000

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