Accuracy Verification of the INVOS PM7100

NCT07166341 | Completed FDA Device

• 1 other identifier: MDT24046IN4WVL
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard

Conditions

Tissue Oxygenation

Keywords

NIRS, INVOS, Tissue Oxygenation, Regional Oxygenation

Outcome Measures

Primary Outcomes (1)

• 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.

  Performance evaluation is expected take approximately 2.5 hours

Secondary Outcomes (2)

• Trend accuracy

  Evaluation is expected take approximately 2.5 hours

• Trend accuracy in a hypercapneic state

  Evaluation is expected take approximately 2.5 hours

Study Arms (1)

Healthy Volunteers

Healthy, non-smoking volunteers ages ≥18 to \<47 years who meet inclusion criteria

Device: Observational

Interventions

Observational DEVICE

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.

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, non-smoking volunteers ages of ≥18 to \<47 years who meet inclusion criteria

You may qualify if:

• 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%

You may not qualify if:

• 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
• 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 \[assessment by PI or delegate\]

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• David MacLeod, MDDS

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: September 29, 2025
• Primary Completion: December 23, 2025
• Study Completion: April 23, 2026
• Last Updated: May 14, 2026

Record last verified: 2025-11

Locations

US (1)