SPO2 VALIDATION STUDY - PHILIPS FAST 2025

Part of paid clinical trials in Louisville, Colorado.

Sponsor
Philips Clinical & Medical Affairs Global
Study ID
NCT07221526
Status
Completed

Conditions

  • PULSE OXIMETRY

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • NO INTERVENTION — DEVICE
    NO INTERVENTION

Study Details

Clinical investigation is to validate the SpO2 accuracy of the M1133AX5, M1133AX6, and AlarX4 (nasal ala application) SpO2 sensors under test with the Philips FAST Pulse Oximetry technology.

Key Dates

First listed
Oct 28, 2025
Start date
Oct 28, 2025
Status verified
Mar 2026
Primary completion
Feb 5, 2026
Completion
Feb 5, 2026

Study Design

Enrollment
86 participants (actual)

Arms

  • Arm: TEST GROUP 1
    Sensor Test Group 1 * AlarX4 (nasal ala placement) * AlarX4 (earlobe placement) * M1131AX1 * M1191BL - As Philips internal silver reference only
  • Arm: TEST GROUP 2
    Sensor Test Group 2 * M1133AX5 * M1133AX6 * M1191BL - As Philips internal silver reference only

Primary Outcome Measure

SPO2 ACCURACY [ Time Frame: OCTOBER 2025-JANUARY 2026 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Element Materials TechnologyLouisvilleColorado80027-

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