HealthyNCT04112784

Desaturation Validation of INVSENSOR00039

A study testing INVSENSOR00039 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

This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Arterial blood samples will be collected from healthy adult subjects while undergoing a desaturation procedure wherein the concentration of oxygen… 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?: INVSENSOR00039
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteUnited States
Study dates: 17 Sep 2019to 9 Oct 2019
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% fraction of carboxyhemoglobin (FCOHb)
Subject has a physical status of 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.
Blood pressure: Systolic Blood Pressure ≤ 140 mmHg and ≥ 90 mmHg, Diastolic Blood Pressure ≤ 90 mmHg and ≥ 50 mmHg, and if blood pressure is lower than 100/60 subject passes an orthostatic blood pressure test.
Subject is able to read and communicate in English and understands the study and risks involved.

Who cannot join

Subject is pregnant.
Subject has a Body Mass Index (BMI) > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after blood draw, or has a fear of blood draws.
Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e- cigarette liquid, and smokers are not being recruited as indicated in the Case Study Report Form (CSRF).
Subject has open wounds, inflamed tattoos or piercings, and/or any visible healing wounds that a medical professional renders them at an increased risk for participation.*
Subject has known drug or alcohol abuse and/or use of recreational drugs.

Show all 31Show fewer

Subject experiences frequent or severe headaches and/or migraine headaches, migraine auras, altitude sickness, and/or headaches accompanied by visual changes or sensitivity to light or sound.
Subject has experienced a concussion or head injury with loss of consciousness within the last 12 months.
Subject has any history of a stroke, myocardial infarction, seizures or heart attack.
Subject has a chronic bleeding disorder (i.e. hemophilia).
Subject who has taken anticoagulant medication within the last 30 days (excluding nonsteroidal anti-inflammatory drugs (NSAIDS)).
Subject has donated blood within the past 4 weeks.
Subject has Wolff-Parkinson-White Syndrome or Stokes-Adams Syndrome.
Subject has any symptomatic cardiac dysrhythmia (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, Multiple Sclerosis, Huntington's Disease) that interferes with the subject's level of consciousness.
Subject has taken opioid pain medication 24 hours before the study.
Subject has any type of infectious disease (i.e. Hepatitis, HIV, Tuberculosis, Flu, Malaria, Measles, etc.).
Subject is taking medications known to treat any type of infectious disease.*
Subject has either signs or history of peripheral ischemia or carpal tunnel syndrome.
Subject has had invasive surgery within the past year- including but not limited to major dental surgery*, appendix*, plastic surgery*.
Subject has had invasive surgery within the past year- including but not limited to gallbladder, major fracture repairs (involving plates/ screws), jaw surgery, urinary tract surgery, major ears, nose, and throat (ENT) surgery, joint replacement or gynecological surgeries, heart surgery or thoracic surgery.
Subject has symptoms of congestion, head cold, 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 any cancer or history of cancer (not including skin cancer).*
Subject has chronic unresolved asthma, lung disease (including chronic obstructive pulmonary disease (COPD)) or respiratory disease.
Subject is allergic to lidocaine, latex, adhesives, or plastic.
Subject has heart conditions, insulin-dependent Diabetes or uncontrolled hypertension.
Subject has delivered vaginally, has had a pregnancy terminated, a miscarriage with hospitalization, or had a C-section within the last 6 months.
Subject intends on participating in any heavy lifting, repetitive movement of their wrist (including riding a motorcycle, tennis) or exercise (working out, riding a bike, riding a skate board etc.), or any activity that will put additional stress on the wrist within 24 hours following a study that involves an arterial line.
Subject has any medical condition which in the judgment of the investigator and/or medical staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.

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

Conditions: Healthy
Being tested: INVSENSOR00039

What participants receive

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

INVSENSOR00039Device
Noninvasive pulse oximeter sensor

Study groups in NCT04112784
Study group	Role	What they receive
INVSENSOR00039	Experimental	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor. Receives: Device: INVSENSOR00039

What is being measured

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

Oxygen Saturation (SpO2) Accuracy of Sensor
Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Accuracy root square mean (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.

17 Sep 20199 Oct 2019

First posted2 Oct 2019
Study start17 Sep 2019
Primary completion9 Oct 2019
Study completion9 Oct 2019

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
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04112784
Sponsor's protocol ID: TP-20068
Status last verified: Sep 2022
First submitted: 30 Sep 2019
Last updated: 6 Oct 2022
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Desaturation Validation of INVSENSOR00039
ClinicalTrials.gov ID: NCT04112784
Acronym / sponsor ID: TP-20068
Conditions: Healthy
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 17 Sep 2019 (actual)
Primary completion: 9 Oct 2019 (actual)
Study completion: 9 Oct 2019 (actual)
First posted: 2 Oct 2019 (actual)
Results: Posted 6 Oct 2022

Clinical summary

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

Study design

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

Arm	Type	Receives
INVSENSOR00039	Experimental	Device: INVSENSOR00039All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00039 sensor.

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% fraction of carboxyhemoglobin (FCOHb)

Key exclusion criteria (31 listed)

Subject is pregnant.
Subject has a Body Mass Index (BMI) > 35 and has been classified as morbidly obese or at an increased risk for participation by a medical professional.
Subject has a history of fainting (vasovagal), blacking out or losing consciousness during or after blood draw, or has a fear of blood draws.
Subject smokes one pack of cigarettes or more in one week, and/or the equivalent of e- cigarette liquid, and smokers are not being recruited as indicated in the Case Study Report Form (CSRF).
Subject has open wounds, inflamed tattoos or piercings, and/or any visible healing wounds that a medical professional renders them at an increased risk for participation.*

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
INVSENSOR00039Noninvasive pulse oximeter sensor	Device	INVSENSOR00039

Primary outcome

Oxygen Saturation (SpO2) Accuracy of Sensor
Time frame: 1-5 hours
Performance of the sensors will be determined by comparing the noninvasive oxygen saturation measurement (SpO2) of the pulse oximeter sensors to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample and calculating the Accuracy root square mean (ARMS) value.

Results and safety

Results posted to the registry on 6 Oct 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INVSENSOR00039	38	25

Primary outcome: Oxygen Saturation (SpO2) Accuracy of Sensor

Time frame: 1-5 hours. Number. Unit: percentage of oxygen saturation

Measure	INVSENSOR00039 n = 25
Value	1.0

Adverse events

Time frame: 1 to 5 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INVSENSOR00039	0 of 25 (0%)	0 of 25 (0%)	0 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy

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Not yet recruitingPhase 1
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Enrolling by invitationObservational study
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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 INVSENSOR00039 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 31 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 6 Oct 2022. 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 6 Oct 2022). 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?

Oxygen Saturation (SpO2) Accuracy of Sensor (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?

On the ClinicalTrials.gov record for NCT04112784.

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 6 Oct 2022.