Oxygen Saturation MeasurementNCT07201961
Nellcor™ Abbreviated Sensor Additional Data Collection
An observational study of Oxygen Saturation Measurement, run by Medtronic - MITG at 1 site in United States.
Trial summary
To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval. Read more about this study
- Who is it for?
- Ages 18 to 51 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation Measurement
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2025to 26 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 51 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy participants ≥ 18 and < 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.
Who may be able to join
- Male or female participants ≥ 18 years of age, and < 51 years of age.
- Participant is willing and able to comply with study procedures and duration.
- Participant is willing to sign an ICF.
- Participant weighs > 40kg (88.2 lb).
- Participant is a non-smoker or has not smoked within 36 hours prior to the study.
- Cleared same day health assessment form and health screening
- Successful perfusion index ulnar/ulnar+radial ratio test (Assessed via the Allen's Test) showing adequate collateral blood flow.
Who cannot join
- Participant is considered as being morbidly obese (defined as BMI >39.5).
- Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized)
- Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study.
- Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
- MetHb ≥ 2% as assessed by CO-Oximetry during the procedure
Show all 53Show fewer
- Participants with known respiratory conditions such as:
- uncontrolled / severe asthma
- flu or influenza type infection
- pneumonia / bronchitis
- shortness of breath / respiratory distress
- unresolved respiratory or lung surgery
- emphysema, COPD, lung disease
- recent COVID (last 2 months)
- Participants with known heart or cardiovascular conditions such as:
- Uncontrolled hypertension (systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings day of screening)
- previous cardiovascular surgery
- chest pain (angina)
- heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
- previous heart attack
- blocked artery
- unexplained shortness of breath
- congestive heart failure (CHF)
- history of stroke and/or transient ischemic attack
- carotid artery disease
- myocardial ischemia
- myocardial infarction
- cardiomyopathy
- implantable active medical device such as pacemaker or automatic defibrillator
- Self-reported health conditions as identified in the Health Assessment Form:
- Diabetes
- uncontrolled thyroid disease
- kidney disease / chronic renal impairment
- history of seizures (except childhood febrile seizures)
- epilepsy
- history of unexplained syncope
- recent history of frequent migraine headaches (within the last 2 months)
- recent symptomatic head injury (within the last 2 months)
- cancer requiring chemotherapy, radiation, or current treatment
- participants with known clotting disorders
- history of bleeding disorders or personal history of prolonged bleeding from injury
- history of blood clots
- hemophilia
- sickle cell trait or disease
- current use of blood thinner: prescription or daily use of aspirin
- participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors
- participants with severe allergy to iodine (only applicable if iodine is used)
- participants with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
- arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
- history of clinically significant complications from previous arterial cannulation
- unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
- other known health condition, upon disclosure in Health Assessment form
- Failure of the Allen's Test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medtronic Clinical Physiology Lab
Denver, Colorado, 80218
About this study
Official title: Verification of Nellcor™ Pulse Oximetry Device With the Nellcor™ Abbreviated Pulse Oximetry Sensor Line in Adult Volunteers
To collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
Read the detailed description
The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.
- Conditions
- Oxygen Saturation Measurement
- Keywords
- Hypoxia, Pulse Oximetry, Healthy Volunteer
- Medical subject headings
- Hypoxia
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™ Pulse Oximetry device with each of the market-released Nellcor™ Pulse Oximetry test sensors. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pulse rate accuracy
Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the pulse rate measurement from the Nellcor Pulse Oximetry device to the heart rate measurements as obtained by ECG.
Measured: 2 - 3 hours
Evaluation of saturation accuracy
Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample.
Measured: 2-3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start24 Jul 2025
- Primary completion26 Aug 2025
- Study completion26 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Saturation MeasurementStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201961
- Sponsor's protocol ID
- MDT25017NQABAD
- Status last verified
- Jul 2025
- First submitted
- 12 Aug 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of Nellcor™ Pulse Oximetry Device With the Nellcor™ Abbreviated Pulse Oximetry Sensor Line in Adult Volunteers
- ClinicalTrials.gov ID
- NCT07201961
- Acronym / sponsor ID
- MDT25017NQABAD
- Conditions
- Oxygen Saturation Measurement
- Keywords
- Hypoxia, Pulse Oximetry, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 26 Aug 2025 (actual)
- First posted
- 1 Oct 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 collect data on a variety of market approved Nellcor™ pulse oximetry sensors with the Nellcor™ Pulse Oximetry device to support the market approval.
Detailed description
The purpose of this study is to collect data on the Nellcor™ Pulse Oximetry device when paired with a variety of Nellcor™ Market Released sensors under invasive, controlled desaturation conditions, to verify Pulse Rate and SpO2 accuracy in a diverse participant population over a specified saturation range.
Study design
- Observational model
- Case only
- 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™ Pulse Oximetry device with each of the market-released Nellcor™ Pulse Oximetry test sensors. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy participants ≥ 18 and < 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.
Key inclusion criteria (7 listed)
- Male or female participants ≥ 18 years of age, and < 51 years of age.
- Participant is willing and able to comply with study procedures and duration.
- Participant is willing to sign an ICF.
- Participant weighs > 40kg (88.2 lb).
- Participant is a non-smoker or has not smoked within 36 hours prior to the study.
Key exclusion criteria (53 listed)
- Participant is considered as being morbidly obese (defined as BMI >39.5).
- Compromised circulation, injury, or physical malformation of fingers, hands, ears or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study. (Note: Certain malformations may still allow participants to participate if the condition is noted and would not affect the sites utilized)
- Participants of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study.
- Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
- tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
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
Evaluation of pulse rate accuracy
Time frame: 2 - 3 hours
Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the pulse rate measurement from the Nellcor Pulse Oximetry device to the heart rate measurements as obtained by ECG.
Evaluation of saturation accuracy
Time frame: 2-3 Months
Performance will be determined by calculating the accuracy in terms of root mean square difference (ARMS) comparing the noninvasive oxygen saturation measurement (SpO2) to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Measurement, 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 7 inclusion and 53 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: finished, as of the sponsor's last update on 12 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of pulse rate accuracy (time frame: 2 - 3 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 12 Mar 2026.