Oxygen SaturationNCT07234279
Nellcor™ Investigational Device Sitting-Walking Study
An observational study of Oxygen Saturation, run by Medtronic - MITG at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2026to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- 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
Who cannot join
- 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
Show all 29Show fewer
- 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
- History of hospital admission or a surgical procedure in the 60 days prior to study enrollment (self-reported)
- Participants with any contraindications to protocol specific repositioning techniques
- Unwillingness or inability to remove colored nail polish from test digit(s)
- Participants who have self-reported health conditions beyond what is captured in the prior exclusion criteria, which in the opinion of the Investigator and/or Clinical Staff would classify the participant as medically unsuitable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ami Stuart contact
United States1 site, 1 recruiting
- Recruiting
Clinical Physiology Lab
Denver, Colorado, 80217
Clinical Research Manager, 303-570-1721, roger.martin-pressman@medtronic.com
About this study
Official title: Feasibility of the Investigational Nellcor™ Investigational Device During Non-Motion and Walking Motion Conditions in Adult Volunteers
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
- Conditions
- Oxygen Saturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | All subjects who meet the inclusion criteria and none of the exclusion criteria will be enrolled into the test group and will participate in data collection with use of the Nellcor™ Investigational device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the investigational device SpO2 as compared to the reference device SpO2
Measured: From enrollment to study exit, 1.5 hours
Accuracy of the investigational device pulse rate as compared to the reference device pulse rate.
Measured: From enrollment to study exit, 1.5 hours
Secondary outcomes (1)
Percentage of the time under evaluation that the NellcorTM Investigational Device provides a SpO2 and PR reading
Measured: From enrollment to study exit, 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start11 Aug 2026
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234279
- Sponsor's protocol ID
- MDT25003NPDSWF
- Status last verified
- Oct 2026
- First submitted
- 14 Nov 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the Investigational Nellcor™ Investigational Device During Non-Motion and Walking Motion Conditions in Adult Volunteers
- ClinicalTrials.gov ID
- NCT07234279
- Acronym / sponsor ID
- MDT25003NPDSWF
- Conditions
- Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –All subjects who meet the inclusion criteria and none of the exclusion criteria will be enrolled into the test group and will participate in data collection with use of the Nellcor™ Investigational device. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (29 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the investigational device SpO2 as compared to the reference device SpO2
Time frame: From enrollment to study exit, 1.5 hours
Accuracy of the investigational device pulse rate as compared to the reference device pulse rate.
Time frame: From enrollment to study exit, 1.5 hours
1 secondary outcome
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 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ami Stuart contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Saturation, run by Medtronic - MITG at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Bowman (720-930-1695, Hannah.bowman@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the investigational device SpO2 as compared to the reference device SpO2 (time frame: From enrollment to study exit, 1.5 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.