Actively Recruiting
NEXT GEN - PHILIPS OPTIMUS
Led by Philips Clinical & Medical Affairs Global · Updated on 2026-04-13
36
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NEXT GEN - PHILIPS OPTIMUS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be able to understand and provide written informed consent.
- Participant must be an adult aged 18 to 50 years.
- Participant must be willing and able to comply with study procedures and duration.
- Participant must be a non-smoker or have not smoked within 2 days prior to the study.
- Participant may be male or female assigned at birth of any race.
You will not qualify if you...
- Participant is morbidly obese with a BMI greater than 39.5.
- Participant has compromised circulation, injury, open wound, physical malformation, or tattoos at sensor sites that limit testing.
- Female participants who are pregnant or trying to get pregnant (with positive pregnancy test confirmation unless not of child-bearing potential).
- Participant smoked within the last 2 days or has carbon monoxide levels above 3%.
- Participant has known respiratory conditions such as uncontrolled severe asthma, flu, pneumonia, bronchitis, respiratory distress, recent COVID within 2 months, or lung diseases.
- Participant has heart or cardiovascular conditions including high blood pressure over specified thresholds, prior heart surgery except minor successful surgery, chest pain, abnormal heart rhythms, previous heart attack, blocked artery, congestive heart failure, stroke, or implanted cardiac devices.
- Participant has health conditions like diabetes, uncontrolled thyroid disease, kidney disease, history of seizures (except childhood febrile), epilepsy, unexplained fainting, recent migraines, recent head injury, or cancer under treatment.
- Participant has clotting disorders or bleeding history, blood clots, hemophilia, uses blood thinners or daily aspirin, or has sickle cell trait or disease.
- Participant has severe skin conditions at sensor sites such as dermatitis, hyperkeratosis, or nail fungus.
- Participant has severe allergies to adhesives, latex, silicone, iodine, lidocaine, or ultrasound gel.
- Participant failed perfusion index ratio test below 0.4.
- Participant unwilling or unable to remove nail polish, artificial nails, or trim nails as needed.
- Participant received intravascular dye within past 48 hours.
- Participant has surgical hardware in the device pathway.
- Participant has uneven skin tone at sensor sites or forehead.
- Participant was previously included in the terminated Optimus Validation study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Element Materials Technology
Louisville, Colorado, United States, 80027
Actively Recruiting
Research Team
D
Dominque Watson
CONTACT
V
Vanessa Assibey-Mensah
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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