HealthyNCT06334055
Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
A study testing Masimo INVSENSOR00073 in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation procedure. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Masimo INVSENSOR00073
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 8 Nov 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Influenced by study design:
- Subject is 18 to 40 years of age.
- Subject weighs a minimum of 110 lbs.
- Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
- Baseline blood pressure:
- Systolic blood pressure ≤ 135 mmHg and ≥ 100 mmHg.
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- Diastolic blood pressure ≤ 95 mmHg and ≥ 55 mmHg.
- Valid systolic blood pressure (SBP) auscultatory measurements for lateral difference is ≤ 15 mmHg.
- Valid diastolic blood pressure (DBP) auscultatory measurements for lateral difference is ≤ 10 mmHg.
- Hemoglobin value ≥ 11 g/dL.
- 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:
- Subject is pregnant or breastfeeding.
- Subject is experiencing dysrhythmia or arrhythmia.
- Influenced by study design/environment:
- Subject is concurrently participating in another research study.
- Subjects not suitable for the investigation at the discretion of the clinical team including but not limited to the items below.
- Subjects who do not pass the health assessment for safe participation in the study procedures.
- Inability to insert or difficulty with 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.
About this study
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation procedure.
- Conditions
- Healthy
- Being tested
- Masimo INVSENSOR00073
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo INVSENSOR00073Device
Noninvasive blood pressure monitor
| Study group | Role | What they receive |
|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. Receives: Device: Masimo INVSENSOR00073 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073
Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.
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 posted27 Mar 2024
- Study start4 Mar 2024
- Primary completion8 Nov 2024
- Study completion8 Nov 2024
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
- 101 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
- NCT06334055
- Sponsor's protocol ID
- CIP-1091
- Status last verified
- Jun 2025
- First submitted
- 21 Mar 2024
- Last updated
- 10 Jul 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 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study of Mean Arterial Pressure (MAP) Parameter of Masimo INVSENSOR00073
- ClinicalTrials.gov ID
- NCT06334055
- Acronym / sponsor ID
- CIP-1091
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 27 Mar 2024 (actual)
- Results
- Posted 10 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to validate the Mean Arterial Pressure (MAP) parameter of Masimo INVSENSOR00073 against the gold standard blood pressure measurements from the arterial line while subject undergo a blood pressure variation procedure.
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: Masimo INVSENSOR00073All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00073 sensor. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Subject is 18 to 40 years of age.
- Subject weighs a minimum of 110 lbs.
- Baseline heart rate ≥ 45 bpm and ≤ 90 bpm.
- Baseline blood pressure:
- Systolic blood pressure ≤ 135 mmHg and ≥ 100 mmHg.
Key exclusion criteria (8 listed)
- Subject is pregnant or breastfeeding.
- Subject is experiencing dysrhythmia or arrhythmia.
- Subject is concurrently participating in another research study.
- Subjects not suitable for the investigation at the discretion of the clinical team including but not limited to the items below.
- 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 |
|---|---|---|
| Masimo INVSENSOR00073Noninvasive blood pressure monitor | Device | Test Subject |
Primary outcome
Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073
Time frame: 1-5 hours.
Accuracy and precision of mean arterial pressure (MAP) measured by Masimo INVSENSOR00073 in comparison to radial arterial line.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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 INVSENSOR00073 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 12 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 10 Jul 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 Jul 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?
Mean Arterial Pressure (MAP) Accuracy and Precision of Masimo INVSENSOR00073 (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 10 Jul 2025.