Recruiting

SpO2 Monitoring

Sponsor:

Masimo Corporation

Code:

NCT07223177

Conditions

SpO2

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

Interventions

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

Study Details

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

Study ID

NCT07223177

Start date

Dec 17, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

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

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 and Locations

Central contacts

Chelsea Frank

949-297-7000clinicalresearchdept@masimo.com

Locations

Paradigm Clinical Research

Recruiting

Modesto, California, United States, 95355

Contacts

Chelsea Frank

949-297-7000

Paradigm Clinical Research

Recruiting

San Diego, California, United States, 92108

Contacts

Chelsea Frank

949-297-7000

More Information

Sponsor

Masimo Corporation

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Masimo Corporation on 2026-07-13.