Nellcor™ Investigational Device Sitting-Walking Study
ConditionOxygen Saturation
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMedtronic - MITG
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Healthy Volunteers
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 1 trial groupGroup A: Healthy Volunteers
Trial outcomes
Primary outcomes
1
Accuracy of the investigational device SpO2 as compared to the reference device SpO2
Time frame
From enrollment to study exit, 1.5 hours2
Accuracy of the investigational device pulse rate as compared to the reference device pulse rate.
Time frame
From enrollment to study exit, 1.5 hoursSecondary outcomes
1
Percentage of the time under evaluation that the NellcorTM Investigational Device provides a SpO2 and PR reading
Time frame
From enrollment to study exit, 1.5 hoursLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: