Nellcor™ Investigational Device Sitting-Walking Study
Starting soon
Conditions studied: Oxygen Saturation
In brief
To examine pulse rate and blood oxygen saturation accuracy of the Nellcor™ Investigational Device during non-motion and walking motion conditions in a diverse patient population through non-invasive means
Key facts
- Study ID
- NCT07234279
- Run by
- Medtronic - MITG
- People needed
- 30
- Starts
- 2026-06-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female participants ≥18 years of age, and <75 years of age.
- Participant is able to participate for the duration of the study
- Participant is willing to sign an informed consent form (ICF)
- Participant weighs > 40kg
- Participants must be a non-smoker or not have smoked within 36 hours prior to the study
You may not qualify if…
- Participant self-reported prior injury or trauma to fingers or hands, which in the opinion of the investigator, may change blood flow or vascular supply and affect the ability to test sensors
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
- Individuals of childbearing potential who are self-reported as pregnant, or who are self-reported as trying to get pregnant
- Morbid obesity (defined as BMI > 39.5)
- Weight > 136 kg
- Participants who self-report problems of unsteadiness or imbalance issues and/or who are unable to walk on a treadmill without holding onto the handrails
- Participant self-reported known heart or cardiovascular conditions such as:
- Uncontrolled hypertension (Systolic pressure ≥ 140mmHg or Diastolic pressure > 90mmHg on 3 consecutive readings day of screening)
- Heart arrhythmias other than sinus arrhythmia (Self-reported and/or as identified on ECG day of screening).
- History of heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure, cardiomyopathy, stroke, transient ischemic attack, or carotid artery disease
- Participants with self-reported clotting disorders, such as:
- History of bleeding disorders or personal history of prolonged bleeding from injury
- History of blood clots
- Hemophilia
- Current use of prescription blood thinner
- Participants with other self-reported, known health conditions, such as:
- Diabetes
- Thyroid disease
- Kidney disease / chronic renal impairment
- History of seizures (except childhood febrile seizures), epilepsy, or unexplained syncope
- Recent history of frequent migraine headaches, as determined medically relevant by the PI
- History of head injury, as determined medically relevant by the PI
- Cancer / chemotherapy
- Sickle cell disease
Full record on ClinicalTrials.gov
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