NEXT GEN - PHILIPS OPTIMUS
ConditionPulse Oximetry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorPhilips Clinical & Medical Affairs Global
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant must have the ability to understand and provide written informed consent.
Participant is an adult between 18-50 years of age.
Participant must be willing and able to comply with study procedures and duration.
Participant is a non-smoker or who has not smoked within 2 days prior to the study.
Disqualifiers
Participant is considered as being morbidly obese (defined as BMI >39.5)
Compromised circulation (i.e., Raynaud's Syndrome), injury, open wound, or physical malformation of fingers, toes, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. Tattoos in the optical path which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized.)
Females who are pregnant
Females who are trying to get pregnant (with confirmation of positive urine pregnancy test unless the participant is known to be not of child-bearing potential)
Trial population
At least 36 participants considered healthy, non-smoking (or have refrained from smoking for 2 days) competent adults, ages 18 to 50 years.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Philips MR400 Pro MRI Patient Monitor
DevicePhilips 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
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Study Population - 18 to 50 Years1 intervention
Trial outcomes
Primary outcomes
1
SpO2 accuracy
SpO2 accuracy will be evaluated for root-mean-square (rms) difference between the DUT and the reference for the specified SpO2 ranges (70-100%) and by SaO2 decade (90-100%, 80\<90%, 70-\<80%).
Time frame
March-April 2026Secondary outcomes
1
Assess Pigmentation
To assess pigmentation differential bias of the SpO2 sensors under non-motion conditions using the Philips MRI Patient Monitoring Pulse Oximetry Subsystem, in accordance with Philips and ISO methods.
Time frame
March-April 2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov