ClinicalTrials.gg
RecruitingNCT07234279Updated Oct 19, 2026

Nellcor™ Investigational Device Sitting-Walking Study

An observational study in Oxygen Saturation, sponsored by Medtronic - MITG. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by Medtronic - MITG (part of Medtronic) · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 19, 2026Now RecruitingFirst site in United States+4 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Oxygen Saturation
03

In context

Lead sponsor

Medtronic - MITG is the lead sponsor of 179 studies on the registry; 5 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Volunteers

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form (ICF)
  • Participant weighs > 40kg
  • Participants must be a non-smoker or not have smoked within 36 hours prior to the study

Exclusion criteria

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 who are self-reported as pregnant, or who are self-reported as trying to get pregnant
  • Morbid obesity (defined as > 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 day of screening).
  • History of heart attack, blocked artery, history of myocardial ischemia, angina, myocardial infarction, congestive heart failure, cardiomyopathy, stroke, , 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 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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 hours

  2. 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

Secondary 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 hours

07

Study locations

1 of 1 sites recruiting
  • Clinical Physiology Lab
    Denver, Colorado 80217, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Aug 2026 (actual). Primary completion is estimated for Oct 2026, 2 months after the start.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 19, 2026: start Jun 2026 → Aug 2026, primary completion Jul 2026 → Oct 2026 and completion Jul 2026 → Oct 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2025
First posted
Nov 18, 2025
StartActual
Aug 11, 2026was Jun 2026
Primary completionEst.
Oct 30, 2026was Jul 2026
CompletionEst.
Oct 30, 2026was Jul 2026
Last update
Oct 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 19, 2026
Sites
1 site added — first site in United States
Show site
  • Clinical Physiology Lab · Denver, United States
Oct 19, 2026
Start date
Jun 2026→Aug 11, 2026 (actual)
Oct 19, 2026
Primary completion
Jul 2026→Oct 30, 2026
Oct 19, 2026
Study completion
Jul 2026→Oct 30, 2026
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    Not yet recruiting→Recruiting
    1 site added — first site in United States
    Show site
    • Clinical Physiology Lab · Denver, United States
    Start date Jun 2026→Aug 11, 2026 (now actual)
    Primary completion Jul 2026→Oct 30, 2026
    Study completion Jul 2026→Oct 30, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07234279
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Nov 18, 2025
Start date
Aug 11, 2026
Primary completion
Oct 30, 2026 (estimated)
Completion
Oct 30, 2026 (estimated)
Last update
Oct 19, 2026

Study contacts

Hannah Bowman
Contact
Hannah.bowman@medtronic.com
720-930-1695
Ami Stuart
Contact
ami.stuart@medtronic.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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