HealthyNCT06149416
SpO2 Accuracy of Noninvasive Pulse Oximeter Sensor With Motion Conditions
A study testing Experimental Masimo RD SET SpO2 Adhesive Sensors in people with Healthy and Hypoxia, run by Stryker Sustainability Solutions at 1 site in United States.
Trial summary
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Experimental Masimo RD SET SpO2 Adhesive Sensors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2023to 28 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- The subject is male or female, aged ≥18 and <50
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English
- The subject has provided informed consent and is willing to comply with the study procedures
Who cannot join
- The subject is obese (BMI>30)
- The subject has a known history of heart disease, lung disease, kidney or liver disease
- Diagnosis of asthma, sleep apnea, or use of CPAP
- Subject has diabetes
- Subject has a clotting disorder
- The subject a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation
Show all 16Show fewer
- The subject has any other serious systemic illness
- The subject is a current smoker
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly
- The subject has a history of fainting or vasovagal response
- The subject has a history of sensitivity to local anesthesia
- The subject has a diagnosis of Raynaud's disease
- The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test)
- The subject is pregnant, lactating or trying to get pregnant
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures
- The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Hypoxia Research Laboratory
San Francisco, California, 94133
About this study
Official title: Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.
Read the detailed description
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz, and 4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to 5Hz.
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. This study should utilize a three level structure (95%, 85% and 75%).
- Being tested
- Experimental Masimo RD SET SpO2 Adhesive Sensors
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Masimo RD SET SpO2 Adhesive SensorsDevice
Masimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arms | Experimental | Experimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors Receives: Device: Experimental Masimo RD SET SpO2 Adhesive Sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours]
The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Measured: 1 - 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start27 May 2023
- Primary completion28 May 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Sustainability Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip Bickler, MD, PhD, Principal investigator, UCSF Hypoxia Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149416
- Sponsor's protocol ID
- CRD10351
- Status last verified
- May 2025
- First submitted
- 20 Nov 2023
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Launch Hypoxia Clinical Study Protocol for Reprocessed Masimo RD SET Pulse Oximeters With Motion
- ClinicalTrials.gov ID
- NCT06149416
- Acronym / sponsor ID
- CRD10351
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Stryker Sustainability SolutionsIndustry (pharma, biotech, devices)
- Study start
- 27 May 2023 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Posted 6 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this clinical study is to validate the SpO2 accuracy of the Stryker Sustainability Solutions pulse oximetry sensors during motion conditions over the range of 70 -100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry during conditions in which the subject is moving. The end goal is to provide supporting documentation for the SpO2 accuracy validation of the reprocessed sensors with motion indications.
Detailed description
In this study, the level of oxygen within the blood will be reduced in a controlled manner by reducing the concentration of oxygen the study volunteer breathes. The accuracy of a noninvasive pulse oximeter sensor will be assessed by comparison to the oxygen saturation measurements from a laboratory blood gas analyzer.
A machine will be used to induce motions of 20 mm during testing at a sine rate of 2Hz, 3Hz, and 4Hz. A third motion moves the arm a random distance of 0 to 30mm at a random speed up to 5Hz.
It is required that the Accuracy Root Mean Square (ARMS) performance of the Stryker pulse oximetry sensors will meet a specification of +/-3% with a target of +/-3% or better in motion conditions for the range of 70 - 100% SaO2 (typically, saturation is determined once with air breathing and then at three or six levels, e.g. 94%, 90%, 85%, 80%, 75% and 70% or 95%, 85% and 75% saturation for about 30-60 seconds or 60-90 seconds at each level), thereby demonstrating an acceptable SpO2 accuracy performance specification. This study should utilize a three level structure (95%, 85% and 75%).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arms | Experimental | Device: Experimental Masimo RD SET SpO2 Adhesive SensorsExperimental: Healthy adult participants All participants are enrolled in the test group and receive the noninvasive adhesive reprocessed pulse oximeter sensors |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- The subject is male or female, aged ≥18 and <50
- The subject is in good general health with no evidence of any medical problems.
- The subject is fluent in both written and spoken English
- The subject has provided informed consent and is willing to comply with the study procedures
Key exclusion criteria (16 listed)
- The subject is obese (BMI>30)
- The subject has a known history of heart disease, lung disease, kidney or liver disease
- Diagnosis of asthma, sleep apnea, or use of CPAP
- Subject has diabetes
- Subject has a clotting disorder
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 |
|---|---|---|
| Experimental Masimo RD SET SpO2 Adhesive SensorsMasimo RD SET SpO2 Adhesive Sensors, Adult (4000 Adt), Adult \& Neonate (4003 Neo) | Device | Experimental Arms |
Primary outcome
Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours]
Time frame: 1 - 5 hours
The outcome of this study is the accuracy of the SpO2 (percent oxygen saturation by pulse oximetry) measured by the Reprocessed Oximeter pulse oximetry sensors during motion conditions over the range of 70 - 100% saturation compared to SaO2 (percent oxygen saturation by co-oximetry from blood samples) from arterial blood samples. The accuracy is calculated using the Arms error between measured SpO2 and reference SaO2. The Arms must meet the 3% specification for each reprocessed pulse oximetry sensor style. Standard deviation of the differences is computed as the precision. Square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Philip Bickler, MD, PhD principal investigator
UCSF Hypoxia Research Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Masimo RD SET SpO2 Adhesive Sensors in people with Healthy and Hypoxia, run by Stryker Sustainability Solutions 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 4 inclusion and 16 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 6 Jun 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?
Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Accuracy of Sensor by Comparing SpO2 Percent Blood Oxygen Saturation to SaO2 Percent Blood Oxygen Saturation Utilizing Arms Calculation Calculation [Time Frame: 1 - 5 Hours] (time frame: 1 - 5 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 6 Jun 2025.