HealthyNCT06120777

Clinical Validation for SpO2 Function of Masimo INVSENSOR00069

A study testing INVSENSOR00069 in people with Healthy, run by Masimo Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: INVSENSOR00069
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2023to 12 Dec 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

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Masimo Corporation
Irvine, California, 92618

Other trials in United States

About this study

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

Conditions: Healthy
Being tested: INVSENSOR00069

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INVSENSOR00069Device
Noninvasive pulse oximeter

Study groups in NCT06120777
Study group	Role	What they receive
Test Subject	Experimental	All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069. Receives: Device: INVSENSOR00069

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1-3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202312 Dec 2023

First posted7 Nov 2023
Study start1 Nov 2023
Primary completion12 Dec 2023
Study completion12 Dec 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: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06120777
Sponsor's protocol ID: CIP-1086
Status last verified: Nov 2024
First submitted: 1 Nov 2023
Last updated: 27 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Validation for SpO2 Function of Masimo INVSENSOR00069
ClinicalTrials.gov ID: NCT06120777
Acronym / sponsor ID: CIP-1086
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 1 Nov 2023 (actual)
Primary completion: 12 Dec 2023 (actual)
Study completion: 12 Dec 2023 (actual)
First posted: 7 Nov 2023 (actual)
Results: Posted 27 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Test Subject	Experimental	Device: INVSENSOR00069All subjects who are enrolled into the test group and participate in data collection have the Masimo INVSENSOR00069.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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).
Subjects who do not pass the health assessment for safe participation in the study procedures.

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
INVSENSOR00069Noninvasive pulse oximeter	Device	Test Subject

Primary outcome

SpO2 Accuracy of Masimo INVSENSOR00069
Time frame: 1-3 hours
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.

Results and safety

Results posted to the registry on 27 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Masimo INVSENSOR00069	89	36

Primary outcome: SpO2 Accuracy of Masimo INVSENSOR00069

Time frame: 1-3 hours. Number. Unit: % of oxygen saturated hemoglobin

Measure	Masimo INVSENSOR00069 n = 23
Value	1.72

Population analysed: 10 subjects not analyzed due to incorrect sensor 3 subjects not analyzed due to not desaturating to the lowest bin (70-80%)

Adverse events

Time frame: 1-3 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Masimo INVSENSOR00069	0 of 86 (0%)	9 of 86 (10.5%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
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 INVSENSOR00069 in people with Healthy, 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 8 inclusion and 8 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 27 Nov 2024. 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 27 Nov 2024). 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 Masimo INVSENSOR00069 (time frame: 1-3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06120777.

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 27 Nov 2024.