Philips FAST Evaluation (NELFST)

July 23, 2025 updated by: Medtronic - MITG

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 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 (Actual)

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.
27

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

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Medtronic Clinical Physiology Lab

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

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Subjects ≥ 18 and < 51 years of age
  2. Subject is willing and able to comply with study procedures and duration
  3. Subject is willing to sign an informed consent
  4. Subject weighs >40kg
  5. Subject is a non-smoker or has not smoked within 36 hours prior to the study
  6. Cleared same day health assessment form and health screening

Exclusion Criteria:

  1. Subject is considered as being morbidly obese (defined as BMI >39.5)
  2. 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)
  3. 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
  4. Subjects with COHb levels >3% as assessed by CO-Oximetry during the procedure
  5. tHb < 10 g/dl as assessed by CO-Oximetry during the procedure
  6. MetHb ≥ 2% as assessed by CO-Oximetry during the procedure

  7. Subjects with known respiratory conditions such as:

    1. uncontrolled / severe asthma
    2. flu or influenza type infection
    3. pneumonia / bronchitis
    4. shortness of breath / respiratory distress
    5. unresolved respiratory or lung surgery
    6. emphysema, COPD, lung disease
    7. recent COVID (last 2 months)

  8. Subjects with known heart or cardiovascular conditions such as:

    1. hypertension: systolic pressure >140mmHg, or diastolic pressure >90mmHg on 3 consecutive readings
    2. previous cardiovascular surgery
    3. chest pain (angina)
    4. heart rhythms other than a normal sinus rhythm or with respiratory sinus arrhythmia (reviewed during health screen)
    5. previous heart attack
    6. blocked artery
    7. unexplained shortness of breath
    8. congestive heart failure (CHF)
    9. history of stroke
    10. transient ischemic attack
    11. carotid artery disease
    12. myocardial ischemia
    13. myocardial infarction
    14. cardiomyopathy
    15. implantable active medical device such as pacemaker or automatic defibrillator

  9. Self-reported health conditions as identified in the Health Assessment Form

    1. diabetes
    2. uncontrolled thyroid disease
    3. kidney disease / chronic renal impairment
    4. history of seizures (except childhood febrile seizures)
    5. epilepsy
    6. history of unexplained syncope
    7. recent history of frequent migraine headaches
    8. recent symptomatic head injury, within the last 2 months
    9. cancer requiring chemotherapy, radiation, or current treatment
    10. subjects with known clotting disorders
    11. history of bleeding disorders or personal history of prolonged bleeding from injury
    12. history of blood clots
    13. hemophilia
    14. sickle cell trait or disease
    15. current use of blood thinner: prescription or daily use of aspirin
    16. 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
    17. participants with severe allergy to iodine (only applicable if iodine is used)
    18. subjects with prior or known severe allergies to lidocaine (or similar pharmacological agents, e.g. Novocain) or heparin
    19. arterial cannulation within the last 30 days prior to study date, (this may exclude only one radial artery site, left or right)
    20. history of clinically significant complications from previous arterial cannulation
    21. Failure of Allen's test
    22. unwillingness or inability to remove colored nail polish or colored artificial nails other than clear from test digits
    23. other known health condition, upon disclosure in Health Assessment form at PI's discretion

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.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Device: Philips FAST SpO2 with Nellcor Pulse Oximetry Sensors
Noninvasive pulse oximeter

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
Measure Description
Time Frame
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.
2 - 3 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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Philips Medical Systems

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Randall M Clark, M.D., Medtronic Clinical Physiology Lab

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 (Actual)

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.
March 11, 2025

Primary Completion (Actual)

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.
April 11, 2025

Study Completion (Actual)

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 11, 2025

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).
February 28, 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.
February 28, 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.
March 5, 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.
July 25, 2025

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.
July 23, 2025

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.
January 1, 2025

More Information

Terms related to this study

Keywords

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.
  • MDT24049NELFST

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.

Yes

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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