Tissue OxygenationNCT07166341
Accuracy Verification of the INVOS PM7100
An observational study of Tissue Oxygenation, run by Medtronic - MITG at 1 site in United States.
Trial summary
Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard Read more about this study
- Who is it for?
- Ages 18 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Tissue Oxygenation
- What is being tested?
- Observational
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2025to 23 Apr 2026
- 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 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy, non-smoking volunteers ages of ≥18 to <47 years who meet inclusion criteria
Who may be able to join
- Healthy subjects between the ages of ≥18 to <47 years
- Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
- Subject is a non-smoker or has not smoked within 2 days prior to the study
- Minimum weight 40kg
- BMI within range 18.0-- 35.0
- Reference tissue hemoglobin oxygen saturation over the range 50% to 85%
Who cannot join
- Compromised circulation, injury, or physical malformation of fingers, hands, or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
- 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 certain medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
- Subject participation will be at the PI's discretion if they are currently participating in, or if they have recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported]
- Negative Allen's test for radial and ulnar patency
Show all 17Show fewer
- 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]
- Individuals of childbearing potential who are pregnant, who are trying to get pregnant, or who have a urine test positive for pregnancy on the day of the study and is unwilling to use effective birth control between the time of screening and study procedure, or is breastfeeding.
- Has anemia [lab values specific for gender]
- 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]
- Has tHb < 10 g/dl as assessed by co-oximetry during the procedure
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Accuracy Performance Verification of the INVOS™ PM7100 System, Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard
Read the detailed description
Verify that the INVOS PM7100 system in conjunction with the INVOS Adult Sensors meets the requirements for tissue saturation accuracy.
- Conditions
- Tissue Oxygenation
- Being tested
- Observational
- Keywords
- NIRS, INVOS, Tissue Oxygenation, Regional Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalDevice
The study objectives require placement of a jugular venous bulb catheter and radial arterial line placement with ultrasound guidance. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead and two on the calf. 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 |
|---|---|---|
| Healthy Volunteers | Healthy, non-smoking volunteers ages ≥18 to <47 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 in terms of the root mean square error
Performance assessed by comparing INVOS™ rSO2 to the calculated global field saturation (fSO2) value obtained from simultaneous arterial and jugular venous blood samples during normocapnia.
Measured: Performance evaluation is expected take approximately 2.5 hours
Secondary outcomes (2)
Trend accuracy
- Cerebral site: Complete system in conjunction with an adult sensor (model PMSENS71-A) shall have an rSO2 trending accuracy over the declared range of 50% to 85% compared to reference hemoglobin tissue oxygen saturation.
- Somatic site: System shall be able to calculate rSO2 on somatic sites.
Measured: Evaluation is expected take approximately 2.5 hours
Trend accuracy in a hypercapneic state
Device performance will be evaluated during hypercapnia
Measured: Evaluation is expected take approximately 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start29 Sep 2025
- Primary completion23 Dec 2025
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tissue OxygenationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David MacLeod, MDDS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166341
- Sponsor's protocol ID
- MDT24046IN4WVL
- Status last verified
- Nov 2025
- First submitted
- 3 Sep 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy Performance Verification of the INVOS™ PM7100 System, Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers
- ClinicalTrials.gov ID
- NCT07166341
- Acronym / sponsor ID
- MDT24046IN4WVL
- Conditions
- Tissue Oxygenation
- Keywords
- NIRS, INVOS, Tissue Oxygenation, Regional Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 10 Sep 2025 (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, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard
Detailed description
Verify that the INVOS PM7100 system in conjunction with the INVOS Adult Sensors meets the requirements for tissue saturation accuracy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: ObservationalHealthy, non-smoking volunteers ages ≥18 to <47 years who meet inclusion criteria |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy, non-smoking volunteers ages of ≥18 to <47 years who meet inclusion criteria
Key inclusion criteria (6 listed)
- Healthy subjects between the ages of ≥18 to <47 years
- Completion of a health screening for medical history by a licensed physician, nurse practitioner, or physician assistant
- Subject is a non-smoker or has not smoked within 2 days prior to the study
- Minimum weight 40kg
- BMI within range 18.0-- 35.0
Key exclusion criteria (17 listed)
- Compromised circulation, injury, or physical malformation of fingers, hands, or forehead/skull or other sensor sites which would limit the ability to test sites needed for the study (Note: certain malformations may still allow subjects to participate if the condition is noted and would not affect the sites utilized)
- 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 certain medication(s) beyond birth control may be excluded from participating at the PI discretion [self-reported]
- Subject participation will be at the PI's discretion if they are currently participating in, or if they have recently participated in (discontinued within 30 days prior to the hypoxia procedure for this study) in an investigational drug, device, or biologic study [self-reported]
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 objectives require placement of a jugular venous bulb catheter and radial arterial line placement with ultrasound guidance. Two INVOS™ sensors (PMSENS71-A) will be placed bilaterally on the subject's forehead and two on the calf. 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 | Healthy Volunteers |
Primary outcome
Accuracy in terms of the root mean square error
Time frame: Performance evaluation is expected take approximately 2.5 hours
Performance assessed by comparing INVOS™ rSO2 to the calculated global field saturation (fSO2) value obtained from simultaneous arterial and jugular venous blood samples during normocapnia.
2 secondary outcomes
Trend accuracy
Time frame: Evaluation is expected take approximately 2.5 hours
Trend accuracy in a hypercapneic state
Time frame: Evaluation is expected take approximately 2.5 hours
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 14 May 2026.
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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.
David MacLeod, MDDS principal investigator
Duke University
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 Tissue Oxygenation, 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 6 inclusion and 17 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 14 May 2026. 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 in terms of the root mean square error (time frame: Performance evaluation is expected take approximately 2.5 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 14 May 2026.