Spo2NCT05896267
SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
A study testing Masimo INVSENSOR00061 in people with Spo2, run by Masimo Corporation at 1 site in United States.
Trial summary
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061. Read more about this study
- Who is it for?
- Ages 37 weeks to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Spo2
- What is being tested?
- Masimo INVSENSOR00061
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2023to 22 Jun 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 37 weeks to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- • Subject is a full-term newborn (37 weeks) to 18 months of age.
Who cannot join
- • Subject has underdeveloped skin.
- Subject has a skin condition and/or deformity at the planned application site, which would preclude sensor placement and measurements.
- Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors.
- Subject is not suitable for the investigation at the discretion of the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
- Conditions
- Spo2
- Being tested
- Masimo INVSENSOR00061
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo INVSENSOR00061Device
Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation )
| Study group | Role | What they receive |
|---|---|---|
| Masimo INVSENSOR00061 | Experimental | Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. Receives: Device: Masimo INVSENSOR00061 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2 Accuracy of INVSENSOR00061
SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.
Measured: Approximately 15 minutes
Pulse Rate Accuracy of INVSENSOR00061
Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.
Measured: Approximately 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 May 2023
- Primary completion22 Jun 2023
- Study completion22 Jun 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 Spo2Studies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896267
- Sponsor's protocol ID
- BAIL0003
- Status last verified
- Oct 2025
- First submitted
- 31 May 2023
- Last updated
- 12 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpO2 Data Collection in Pediatric Patients Using INVSENSOR00061
- ClinicalTrials.gov ID
- NCT05896267
- Acronym / sponsor ID
- BAIL0003
- Conditions
- Spo2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 May 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Posted 12 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, non-randomized data collection study to evaluate the form, fit, and function of INVSENSOR00061.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Masimo INVSENSOR00061 | Experimental | Device: Masimo INVSENSOR00061Experimental: INVSENSOR00061 All subjects are enrolled into this arm will have noninvasive blood oxygen measurements obtained. |
Who may qualify
- Ages
- 37 weeks to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- • Subject is a full-term newborn (37 weeks) to 18 months of age.
Key exclusion criteria (4 listed)
- • Subject has underdeveloped skin.
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 |
|---|---|---|
| Masimo INVSENSOR00061Masimo INVSENSOR00061 will be used to measure noninvasive SpO2 (Oxygen Saturation ) | Device | Masimo INVSENSOR00061 |
Primary outcome
SpO2 Accuracy of INVSENSOR00061
Time frame: Approximately 15 minutes
SpO2 accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value which will be reported as percent of oxygen saturated hemoglobin. The noninvasive oxygen saturation measurement (SpO2) from the INVSENSOR00061 will be compared to the noninvasive oxygen saturation measurement (SpO2) value from the RD SET Neo sensor.
Pulse Rate Accuracy of INVSENSOR00061
Time frame: Approximately 15 minutes
Pulse Rate accuracy will be determined by calculating the Arithmetic Root Mean Square (ARMs) value through the comparison of the noninvasive Pulse Rate to the noninvasive Pulse Rate (PR) value obtained from the RD SET Neo sensor which will be reported as beats per minute.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing Masimo INVSENSOR00061 in people with Spo2, run by Masimo Corporation 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 1 inclusion and 4 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 Nov 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 12 Mar 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?
SpO2 Accuracy of INVSENSOR00061 (time frame: Approximately 15 minutes). 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 Nov 2025.