Nellcor™ Investigational Device Sitting-Walking Study

NCT07234279 | Not Yet Recruiting

• 1 other identifier: MDT25003NPDSWF
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Oxygen Saturation

Outcome Measures

Primary Outcomes (2)

• Accuracy of the investigational device SpO2 as compared to the reference device SpO2

  From enrollment to study exit, 1.5 hours

• Accuracy of the investigational device pulse rate as compared to the reference device pulse rate.

  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

  From enrollment to study exit, 1.5 hours

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Central Study Contacts

Hannah Bowman

CONTACT

720-930-1695; Hannah.bowman@medtronic.com

Ami Stuart

CONTACT

ami.stuart@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: March 1, 2026
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share