Oxygen SaturationNCT06581835
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
An observational study of Oxygen Saturation, run by Medtronic - MITG at 1 site in United States.
Trial summary
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Saturation
- What is being tested?
- Observational
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2024to 22 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria
Who may be able to join
- Subjects between the ages of 18 to 50 years
- Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
- Minimum weight 40kg
- BMI within range 18.0 - 29.9
Who cannot join
- Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported]
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
- Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
- Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
- Negative Allen's test for radial and ulnar patency
- Has made a whole blood donation or has had at least 450 ml of blood drawn within 8 weeks prior to the study procedure [self-reported]
Show all 15Show fewer
- Is pregnant
- Has anemia as measured by co-oximetry [values specific for sex]
- Has a history of sickle cell trait or thalassemia [self-reported]
- Has an abnormal hemoglobin electrophoresis test [lab measurement]
- Has a positive urine cotinine test or urine drug screen or oral ethanol test [Point of Care (POC) testing]
- Has a room air saturation less than 95% by pulse oximetry [measurement by PI or delegate]
- Has a clinically significant abnormal ECG [assessment by PI or delegate]
- Has a clinically significant abnormal pulmonary function test via spirometry [assessment by PI or delegate]
- Has a COHb greater than 3%, or MetHb greater than 2% [measured by venous blood sample co-oximetry]
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard
Read the detailed description
The purpose of this study is to provide data for verification of the INVOS™ PM7100 System paired with the Adult Sensor (PMSENS71-A). Medtronic evaluates the performance and/or feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations. This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples (SaO2) and (SjvO2) and the composite of the two (SavO2) as measured by co-oximetry.
- Conditions
- Oxygen Saturation
- Being tested
- Observational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalDevice
The study objective requires placement of a jugular venous bulb catheter in the right or left jugular venous bulb with ultrasound guidance. A venous and radial arterial line will be placed. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration.
| Study group | Role | What they receive |
|---|---|---|
| Observational | Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria Receives: Device: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy root mean square
Accuracy root mean square is the square-root of the average squared distances between regional oxygen saturation (rSO2) as measured by INVOS and and field saturation (fSO2) as measured by blood sampling
Measured: rSO2 and fSO2 data are recorded every 5-minutes during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start21 Oct 2024
- Primary completion20 Mar 2025
- Study completion22 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen SaturationStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581835
- Sponsor's protocol ID
- MDT23038INSENS
- Status last verified
- Jul 2024
- First submitted
- 23 Aug 2024
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Performance Verification of the INVOS™ PM7100 System by Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
- ClinicalTrials.gov ID
- NCT06581835
- Acronym / sponsor ID
- MDT23038INSENS
- Conditions
- Oxygen Saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 22 Jul 2025 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard
Detailed description
The purpose of this study is to provide data for verification of the INVOS™ PM7100 System paired with the Adult Sensor (PMSENS71-A). Medtronic evaluates the performance and/or feasibility of non-invasive optical devices over a clinically relevant range of arterial saturations. This study evaluates rSO2 accuracy of tissue oximetry equipment compared directly to the actual saturation of arterial and jugular blood samples (SaO2) and (SjvO2) and the composite of the two (SavO2) as measured by co-oximetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Device: ObservationalHealthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria
Key inclusion criteria (4 listed)
- Subjects between the ages of 18 to 50 years
- Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
- Minimum weight 40kg
- BMI within range 18.0 - 29.9
Key exclusion criteria (15 listed)
- Prior or known allergies to lidocaine (or similar pharmacologic agents, e.g., Novocain) [self-reported]
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
- Subjects taking medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
- Any interventional study within 30 days that, in the opinion of the PI, electrocardiogram (ECG) may interfere with study participation (i.e., drug, biologic)
- Negative Allen's test for radial and ulnar patency
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 |
|---|---|---|
| ObservationalThe study objective requires placement of a jugular venous bulb catheter in the right or left jugular venous bulb with ultrasound guidance. A venous and radial arterial line will be placed. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead. The INVOS™ device will be evaluated for a targeted range of 70-100% SpO2 levels. Hypoxic mixtures of gas are delivered, and data are collected at approximately (~) 5-minute intervals during steady periods of increasing and decreasing oxygen concentration. | Device | Observational |
Primary outcome
Accuracy root mean square
Time frame: rSO2 and fSO2 data are recorded every 5-minutes during the procedure
Accuracy root mean square is the square-root of the average squared distances between regional oxygen saturation (rSO2) as measured by INVOS and and field saturation (fSO2) as measured by blood sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Oxygen Saturation, run by Medtronic - MITG 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 4 inclusion and 15 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 25 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Accuracy root mean square (time frame: rSO2 and fSO2 data are recorded every 5-minutes during the procedure). 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 25 Jul 2025.