Oxygen SaturationNCT04894669
Convenience Sample Data Collection for INVSENSOR00045
A study testing INVSENSOR00045 in people with Oxygen Saturation, run by Masimo Corporation at 1 site in United States.
Trial summary
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter. Read more about this study
- Who is it for?
- Ages Up to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- INVSENSOR00045
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jun 2021to 21 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 Up to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Less than or equal to 1 month of age
- Gestational age greater than 23 weeks
- Weight less than or equal to 5 kg
- Subjects with standard of care arterial blood sampling line already in place
Who cannot join
- Subjects with underdeveloped skin
- Subjects with abnormalities at the planned application sites that would interfere with system measurements
- Subjects with known allergic reactions to foam/rubber products and adhesive tape
- Subjects with axillary arterial lines
- Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
Trial locations and contacts
1 site in 1 country.
About this study
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
- Conditions
- Oxygen Saturation
- Being tested
- INVSENSOR00045
- Keywords
- Oxygen Saturation, SpO2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVSENSOR00045Device
Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate.
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00045 | Experimental | All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital. Receives: Device: INVSENSOR00045 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Form, Fit and Function of INVSENSOR00045.
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
Measured: Up to 8 hours per subject.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start11 Jun 2021
- Primary completion21 May 2023
- Study completion21 May 2023
Why it stopped: Sponsor Decision
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 Oxygen SaturationStudies 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 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
- NCT04894669
- Sponsor's protocol ID
- CHOC0006
- Status last verified
- Feb 2025
- First submitted
- 17 Mar 2021
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Convenience Sample Data Collection for INVSENSOR00045
- ClinicalTrials.gov ID
- NCT04894669
- Acronym / sponsor ID
- CHOC0006
- Conditions
- Oxygen Saturation
- Keywords
- Oxygen Saturation, SpO2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 21 May 2023 (actual)
- Study completion
- 21 May 2023 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical investigation is to collect data to provide additional support for form, fit, and function of INVSENSOR00045 in the neonatal clinical environment when used by hospital's personnel and reference co-oximeter.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00045 | Experimental | Device: INVSENSOR00045All subjects are enrolled into the test group and are fitted with a non-invasive pulse oximetry sensor called INVSENSOR00045 during their stay at the hospital. |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Less than or equal to 1 month of age
- Gestational age greater than 23 weeks
- Weight less than or equal to 5 kg
- Subjects with standard of care arterial blood sampling line already in place
Key exclusion criteria (5 listed)
- Subjects with underdeveloped skin
- Subjects with abnormalities at the planned application sites that would interfere with system measurements
- Subjects with known allergic reactions to foam/rubber products and adhesive tape
- Subjects with axillary arterial lines
- Deformities of the limbs, absence of the feet, severe edema, and other at the discretion of the Principal Investigator
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 |
|---|---|---|
| INVSENSOR00045Noninvasive sensor will be fitted to the subject's hand, foot, or toe to measure oxygen saturation and pulse rate. | Device | INVSENSOR00045 |
Primary outcome
Form, Fit and Function of INVSENSOR00045.
Time frame: Up to 8 hours per subject.
To observe form, fit, and function of the INVSENSOR00045 sensors in the neonatal population with convenience sampling in a clinical environment. Data collected using the sensors will be compared to the reference values (RMS).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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 INVSENSOR00045 in people with Oxygen Saturation, 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Apr 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 10 Apr 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?
Form, Fit and Function of INVSENSOR00045. (time frame: Up to 8 hours per subject.). 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 10 Apr 2025.