Nellcorâ„¢ Investigational Device Sitting-Walking Study (NCT07234279) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Nellcorâ„¢ Investigational Device Sitting-Walking Study
30 participantsStarted 2026-03
Plain-language summary
To examine pulse rate and blood oxygen saturation accuracy of the Nellcorâ„¢ Investigational Device during non-motion and walking motion conditions in a diverse patient population through non-invasive means
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 myoca…
What they're measuring
1
Accuracy of the investigational device SpO2 as compared to the reference device SpO2
Timeframe: From enrollment to study exit, 1.5 hours
2
Accuracy of the investigational device pulse rate as compared to the reference device pulse rate.
Timeframe: From enrollment to study exit, 1.5 hours