HealthyNCT03396835
Desaturation Validation of INVSENSOR00009
A study testing INVSENSOR00009 in people with Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. 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?
- INVSENSOR00009
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2017to 16 Jan 2018
- 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
- Subject is 18-50 years of age.
- Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- Hemoglobin value is greater than or equal to 11 g/dL.
- Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
- Carbon monoxide (CO) value ≤ 2.0% FCOHb (Fractional saturation of hemoglobin with Carbon monoxide)
- Subject has a physical status of American Society of Anesthesiology (ASA) I or II (American Society of Anesthesiology Class I; Healthy subjects without any systemic disease at all. American Society of Anesthesiology Class II; subjects with mild systemic disease) as it applies to the systemic disease portion of the classification.
- Systolic Blood Pressure ≤ 140 mmHg and Diastolic Blood Pressure ≤ 90 mmHg.
- Subject is able to read and communicate in English and understands the study and risks involved.
Who cannot join
- Subject is pregnant.
- Subject smokes (smoking includes e-cigarette use).
- Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
- Subject has open wounds, inflamed tattoos or piercings, visible healing wounds.
- Subject experiences frequent or severe headaches and/or migraine headaches.
- Subject has known drug or alcohol abuse and/or use of recreational drugs.
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- Subject has experienced a concussion or head injury with loss of consciousness within the last year.
- Subject has any chronic bleeding disorders (i.e. hemophilia).
- Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
- Subject has any cancer or history of cancer (not including skin cancer).
- Subject has a chronic neurological disease (i.e. multiple sclerosis, Huntington's Disease).
- Subject has any cardiac dysrhythmia(s) (i.e. atrial fibrillation) and has not received clearance by their physician to participate.
- Subject has a known neurological and/or psychiatric disorder (i.e. schizophrenia, bipolar disorder) that interferes with the subject's level of consciousness.
- Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study (Discretion of investigator).
- Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
- Subject who has taken anticoagulant medication within the last 30 days.
- Subject has taken opioid pain medication within 24 hours of start of study.
- Subject has either signs or history of peripheral ischemia.
- Subject has had invasive surgery within the past year- including but not limited to major dental surgery, gallbladder, heart, appendix, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, plastic surgery, major ear nose and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
- Subject has donated blood within the past 30 days.
- Subject has symptoms of congestion, head colds, flu or other illnesses.
- Subject experiences claustrophobia or has generalized anxiety disorder.
- Subject has been in severe car accident(s) or a similar type of accident(s) requiring hospitalization within the last 12 months.
- Subject has chronic unresolved asthma, lung disease or respiratory disease.
- Subject is allergic to lidocaine, latex, adhesives, or plastic.
- Subject has heart conditions, insulin-dependent diabetes or uncontrolled hypertension.
- Subject has given vaginal delivery, had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
- Discretion of investigator/study staff.
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
- Conditions
- Healthy
- Being tested
- INVSENSOR00009
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INVSENSOR00009Device
All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00009 Sensor | Experimental | All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. Receives: Device: INVSENSOR00009 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation
Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects. Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) value.
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 posted11 Jan 2018
- Study start18 Dec 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
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
- 16 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
- NCT03396835
- Sponsor's protocol ID
- TP-19029
- Status last verified
- Aug 2019
- First submitted
- 5 Jan 2018
- Last updated
- 28 Aug 2019
- 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desaturation Validation of INVSENSOR00009
- ClinicalTrials.gov ID
- NCT03396835
- Acronym / sponsor ID
- TP-19029
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to measure the trending accuracy of a noninvasive measurement of cerebral oxygen saturation. One Large sensor (adult sensor) and one INVSENSOR00009 will be placed on the subject's forehead. The values obtained by the INVSENSOR00009 will be compared to the values collected with the adult sensor.Data will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen saturation is approximately 70%. The subject will then be returned to inhaling room air.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00009 Sensor | Experimental | Device: INVSENSOR00009All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject is 18-50 years of age.
- Subject weighs a minimum of 110 lbs and no more than 250 lbs unless subject is over 6 feet tall.
- Hemoglobin value is greater than or equal to 11 g/dL.
- Baseline heart rate ≥ 45 bpm and ≤ 85 bpm.
- Carbon monoxide (CO) value ≤ 2.0% FCOHb (Fractional saturation of hemoglobin with Carbon monoxide)
Key exclusion criteria (28 listed)
- Subject is pregnant.
- Subject smokes (smoking includes e-cigarette use).
- Subject has a BMI > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
- Subject has open wounds, inflamed tattoos or piercings, visible healing wounds.
- Subject experiences frequent or severe headaches and/or migraine headaches.
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 |
|---|---|---|
| INVSENSOR00009All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead. | Device | INVSENSOR00009 Sensor |
Primary outcome
Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation
Time frame: 1-5 hours
Trending ARMs accuracy is defined as root mean squared relative error of all data points of all subjects. Accuracy of the sensors will be determined by comparing regional oxygen saturation (rSO2) readings from INVSENSOR00009 and control sensor and calculating the Arithmetic root mean square (ARMS) value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- 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 INVSENSOR00009 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 28 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 28 Aug 2019. 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 28 Aug 2019). 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?
Trending Regional Oxygen Saturation Accuracy of the INVSENSOR00009 Relative to the Control Sensor by Arms Calculation (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 28 Aug 2019.