New oxygen monitor tested in healthy volunteers
NCT ID NCT07166341
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed study tested the accuracy of the INVOS PM7100, a device that measures oxygen levels in tissues. Forty-eight healthy adults had sensors placed on their forehead and calf while breathing different oxygen mixtures. The device's readings were compared to oxygen levels in blood samples to see how well it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could confirm that the INVOS PM7100 device reliably measures tissue oxygen, helping doctors monitor patients during surgery or critical care.
- What could go wrong
- This was a small, early-stage verification study in healthy volunteers, not patients. Real-world performance may differ, and the device is not a treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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48 people
The number who actually took part.
- Started
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Sep 2025
- Finished
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Apr 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Healthy, non-smoking volunteers ages of ≥18 to \<47 years who meet inclusion criteria
- Ages
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18 to 46 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy subjects between the ages of ≥18 to \<47 years * Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant * Subject is a non-smoker or has not smoked within 2 days prior to the study * Minimum weight 40kg * BMI within range 18.0-- 35.0 * Reference tissue hemoglobin oxygen saturation over the range 50% to 85% Exclusion Criteria: * Compromised circulation, injury, or physical malformation of fingers, hands, or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized) * Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) \[self-reported\] * Prior known severe allergies to medical grade adhesive/tape (Band-Aid) \[self-reported\] * Subjects taking certain medication(s) beyond birth control may be excluded from participating at the PI discretion \[self-reported\] * Subject participation will be at the PI's discretion if they are currently participating in, or if they have recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study \[self-reported\] * Negative Allen's test for radial and ulnar patency * Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure \[self-reported\] * Individuals of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study and is unwilling to use effective birth control between the time of screening and study procedure, or is breastfeeding. * Has anemia \[lab values specific for gender\] * Has a history of sickle cell trait or thalassemia \[self-reported\] * Has an abnormal hemoglobin electrophoresis test \[lab measurement\] * Has a positive urine cotinine test or urine drug screen or oral ethanol test \[Point of Care (POC) testing\] * Has a room air saturation less than 95% by pulse oximetry \[measurement by PI or delegate\] * Has a clinically significant abnormal ECG \[assessment by PI or delegate\] * Has a clinically significant abnormal pulmonary function test via spirometry \[assessment by PI or delegate\] * Has a COHb greater than 3%, or MetHb greater than 2% \[measured by venous blood sample co-oximetry\] * Has tHb \< 10 g/dl as assessed by co-oximetry during the procedure
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Duke University Medical Center
Durham, North Carolina, 27710, United States