Oxygen Saturation MeasurementNELFSTNCT06860230
Philips FAST Evaluation
An observational study of Oxygen Saturation Measurement, run by Medtronic - MITG at 1 site in United States.
Trial summary
Evaluation of Philips FAST technology with Nellcor sensors Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation Measurement
- What is being tested?
- Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors
- Type of treatment
- Medical device
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2025to 11 Jul 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy subjects ≥ 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
- Subjects ≥ 18 and < 51 years of age
- Subject is willing and able to comply with study procedures and duration
- Subject is willing to sign an informed consent
- Subject weighs >40kg
- Subject is a non-smoker or has not smoked within 36 hours prior to the study
- Cleared same day health assessment form and health screening
Who cannot join
- Subject 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 subjects 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 54Show fewer
- Subjects 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)
- Subjects with known heart or cardiovascular conditions such as:
- hypertension: systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings
- 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
- 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
- recent symptomatic head injury, within the last 2 months
- cancer requiring chemotherapy, radiation, or current treatment
- subjects 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
- subjects 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)
- subjects 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
- Failure of Allen's test
- 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 at PI's discretion
Trial locations and contacts
1 site in 1 country.
United States1 site
Medtronic Clinical Physiology Lab
Denver, Colorado, 80218
About this study
Official title: Evaluation of NellcorTM Pulse Oximetry Accuracy With the Philips picoSAT X SpO2 Board With Fourier Artifact Suppression Technology in Adult Volunteers
Evaluation of Philips FAST technology with Nellcor sensors
Read the detailed description
Evaluate saturation accuracy claims for the Philips picoSAT X SpO2 board with FAST algorithm, paired with Nellcor™ sensors in a diverse subject population, over a specified saturation range
- Conditions
- Oxygen Saturation Measurement
- Being tested
- Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors
- Keywords
- pulse oximetry, Hypoxia
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Philips FAST SpO2 with Nellcor Pulse Oximetry SensorsDevice
Noninvasive pulse oximeter
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | All subjects who meet the inclusion criteria are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors Receives: Device: Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start11 Mar 2025
- Primary completion11 Apr 2025
- Study completion11 Jul 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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Philips Medical Systems
- Responsible party
- Sponsor
- Investigators
- Randall M Clark, M.D., Principal investigator, Medtronic Clinical Physiology Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860230
- Sponsor's protocol ID
- MDT24049NELFST
- Acronym
- NELFST
- Status last verified
- Jan 2025
- First submitted
- 28 Feb 2025
- Last updated
- 25 Jul 2025
- 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 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NellcorTM Pulse Oximetry Accuracy With the Philips picoSAT X SpO2 Board With Fourier Artifact Suppression Technology in Adult Volunteers
- ClinicalTrials.gov ID
- NCT06860230
- Acronym / sponsor ID
- NELFST / MDT24049NELFST
- Conditions
- Oxygen Saturation Measurement
- Keywords
- pulse oximetry, Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Collaborators
- Philips Medical Systems
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 11 Apr 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 5 Mar 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.
Evaluation of Philips FAST technology with Nellcor sensors
Detailed description
Evaluate saturation accuracy claims for the Philips picoSAT X SpO2 board with FAST algorithm, paired with Nellcor™ sensors in a diverse subject population, over a specified saturation range
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Philips FAST SpO2 with Nellcor Pulse Oximetry SensorsAll subjects who meet the inclusion criteria are enrolled into the test group and participate in data collection have the Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy subjects ≥ 18 and < 51 years of age, with varying skin tones and diversity across ethnicity, race, gender, and sex assigned at birth.
Key inclusion criteria (6 listed)
- Subjects ≥ 18 and < 51 years of age
- Subject is willing and able to comply with study procedures and duration
- Subject is willing to sign an informed consent
- Subject weighs >40kg
- Subject is a non-smoker or has not smoked within 36 hours prior to the study
Key exclusion criteria (54 listed)
- Subject 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 subjects 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Philips FAST SpO2 with Nellcor Pulse Oximetry SensorsNoninvasive pulse oximeter | Device | Healthy Volunteers |
Primary outcome
Evaluation of Saturation Accuracy
Time frame: 2 - 3 hours
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 25 Jul 2025.
Related trials for Oxygen Saturation Measurement
Not yet recruitingObservational study
Continuous Assessment of Brain Blood Perfusion in Subarachnoid Hemorrhage Patients Using Near-Infrared Spectroscopy (NIRS)
Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingObservational study
Flap Assessment With Regional Oximetry for Early Detection of Compromise in Free Flap Reconstructive Surgery - FLARE Study
Reconstructive Surgery, Flap Monitoring
Recruiting
Temporal Dynamics of Peripheral SpO₂ During Reoxygenation
Healthy Vollunteer, Apnea
Enrolling by invitationObservational study
ETCO₂ Targeting and Cerebral Oxygenation
Airway Reactivity, Hemodynamic Stability During Anesthesia
Recruiting
Transoral Nasal Cannula Oxygen Therapy for Mouth-Breathing Patients in the Postanesthesia Care Unit
Postoperative Hypoxemia
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.
Randall M Clark, M.D. principal investigator
Medtronic Clinical Physiology Lab
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 6 inclusion and 54 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 25 Jul 2025. 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 Saturation Accuracy (time frame: 2 - 3 hours). 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 25 Jul 2025.