CompletedNCT06120777Updated Nov 27, 2024Results posted

Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

An interventional study of INVSENSOR00069 in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-27.

Sponsored by Masimo Corporation (part of Danaher Corporation) · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 89
Allocation: Not applicable
Ages: 18 Years to 50 Years
Sex: All

Study summary

Assess the accuracy of INVSENSOR00069's peripheral oxygen saturation (SpO2) against contemporaneous measurement from arterial blood gas (ABG) analysis.

Conditions studied

Healthy

In context

Lead sponsor

Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.

Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.

First submitted before Masimo Corporation became part of Danaher Corporation.

Browse Masimo Corporation studies →All Danaher Corporation studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Influenced by study design:

Subject is 18 to 50 years of age.
Subject weighs a minimum of 110 lbs.
Hemoglobin value ≥ 11 g/dL.
Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
Systolic blood pressure ≤ 140 mmHg and ≥ 90 mmHg and diastolic blood pressure ≤ 90 mmHg and ≥ 50 mmHg. If systolic blood pressure is lower than 100 mmHg and/or diastolic blood pressure is lower than 60 mmHg, subject passes an orthostatic blood pressure test.
CO value ≤ 3.0% FCOHb.
Subject is comfortable to read and communicate in English*. *This is to ensure the subject can provide informed consent (as study materials are currently available in English only) and can comply with study procedures.

Exclusion criteria

Exclusion Criteria:

Influenced by device warning labels:

Subjects with a skin condition affecting the digits, where the sensor is applied, which would interfere with the path of light (e.g., psoriasis, vitiligo, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown, etc.).
Subjects with nail polish or acrylic nails on the digits where sensor needs to be applied, who opt not to remove them.
Subject has hemoglobinopathies or synthesis disorders (e.g., thalassemia, sickle cell disease).
Subject has a peripheral vascular or vasospastic disease (e.g., Raynaud's disease).

Influenced by study design/environment:

Subjects who do not pass the health assessment for safe participation in the study procedures.
Difficulty inserting an intravenous line in the subject's hand or arm and/or an arterial line in the radial artery of the subject's wrist.

Study design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 89 participants (actual)

Study arms

Experimental
Test Subject
All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.
Device: INVSENSOR00069

Interventions

DeviceINVSENSOR00069
Noninvasive pulse oximeter

What researchers measure

Primary outcomes

SpO2 Accuracy of Masimo INVSENSOR00069
The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.
Time frame: 1-3 hours

Results

Posted Nov 27, 2024

Participant flow

Participant flow — Overall Study
Milestone	Masimo INVSENSOR00069
Started	89
Completed	36
Not completed	53

Outcome measures

PrimarySpO2 Accuracy of Masimo INVSENSOR00069

The SpO2 accuracy of Masimo INVSENSOR00069 was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.

Time frame:: 1-3 hours
Reported as:: Number · % of oxygen saturated hemoglobin

SpO2 Accuracy of Masimo INVSENSOR00069
% of oxygen saturated hemoglobin	Masimo INVSENSOR00069
SpO2 Accuracy of Masimo INVSENSOR00069	1.72

Adverse events

Collected over 1-3 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Masimo INVSENSOR00069	0/86 (0%)	0/86 (0%)	9/86 (10.5%)

Most frequent other events

Most frequent other events
Event	Masimo INVSENSOR00069
Dizziness/LightheadednessNervous system disorders	5/86
NauseaGastrointestinal disorders	1/86
HypotensionCardiac disorders	1/86
Increased heart rateCardiac disorders	1/86
NumbnessNervous system disorders	1/86

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Masimo INVSENSOR00069
<=18 years	0
Between 18 and 65 years	36
>=65 years	0

Sex: Female, Male
Sex: Female, Male(Participants)	Masimo INVSENSOR00069
Female	15
Male	21

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Masimo INVSENSOR00069
American Indian or Alaska Native	0
Asian	5
Native Hawaiian or Other Pacific Islander	0
Black or African American	11
White	13
More than one race	2
Unknown or Not Reported	5

Region of Enrollment
Region of Enrollment(participants)	Masimo INVSENSOR00069
United States	36

Study locations

1 site

Masimo Corporation
Irvine, California 92618, United States

References and documents

Study documents

Protocol and statistical analysis plan · Aug 23, 2023

Documents are hosted by the registry — open the source record to download them.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2023 to primary completion in Dec 2023, 1 month.

Results were first posted in Nov 2024, 11 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 1, 2023
First posted: Nov 7, 2023
StartActual: Nov 1, 2023
Primary completionActual: Dec 12, 2023
CompletionActual: Dec 12, 2023
Results first posted: Nov 27, 2024
Last update: Nov 27, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Nov 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06120777
Lead sponsor: Masimo Corporation
Responsible party: Sponsor
First posted: Nov 7, 2023
Start date: Nov 1, 2023
Primary completion: Dec 12, 2023
Completion: Dec 12, 2023
Results posted: Nov 27, 2024
Last update: Nov 27, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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