NEXT GEN - PHILIPS OPTIMUS

Conditions

• Pulse Oximetry

Eligibility Criteria

Sex

ALL

Age

18 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Philips MR400 Pro MRI Patient Monitor — DEVICE
  Philips IntelliVue Patient Monitor X3 Philips Adult SpO2 Sensor (M1191BL) Philips Wireless Patient Module SpO2 (Gen-4) SpO2 Sensor, MRI (Gen-4) Adult SpO2 Glove Adult SpO2 Grips

Study Details

The purpose of this clinical study is to validate the SpO2 accuracy performance of the sponsor's SpO2 sensors over the range of 70-100% SaO2 during non-motion conditions assessed by CO-Oximetry.

Key Dates

First listed

Apr 13, 2026

Start date

Mar 9, 2026

Status verified

Jul 2026

Primary completion

Mar 31, 2026

Completion

Mar 31, 2026

Study Design

Enrollment

46 participants (actual)

Arms

• Arm: Study Population - 18 to 50 Years
  The study population will include a minimum of 36 participants up to a maximum of 72, healthy male and female volunteers of any race, ranging in pigmentation from light to dark.

Primary Outcome Measure

SpO2 accuracy [ Time Frame: March-April 2026 ]

Locations (1)

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