Nellcor™ Investigational Device Sitting-Walking Study

May 12, 2026 updated by: Medtronic - MITG

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Accuracy of the investigational device SpO2 as compared to the reference device SpO2
Time Frame: From enrollment to study exit, 1.5 hours
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
From enrollment to study exit, 1.5 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
From enrollment to study exit, 1.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic - MITG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MDT25003NPDSWF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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