CClinicalTrials.gg
Not yet recruitingNCT07234279Updated May 14, 2026

Nellcor™ Investigational Device Sitting-Walking Study

An observational study in Oxygen Saturation, sponsored by Medtronic - MITG. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Medtronic - MITG · Observational

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

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

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

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 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
04

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.

05

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

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07234279
Lead sponsor
Medtronic - MITG
Responsible party
Sponsor
First posted
Nov 18, 2025
Start date
Jun 2026 (estimated)
Primary completion
Jul 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 14, 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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion