Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

NCT06581835 | Completed FDA Device

• 1 other identifier: MDT23038INSENS
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, observational, post-market, verification study to ensure compliance to the ISO 80601-2-85:2021 standard

Conditions

Oxygen Saturation

Outcome Measures

Primary Outcomes (1)

• 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

  rSO2 and fSO2 data are recorded every 5-minutes during the procedure

Study Arms (1)

Observational

Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria

Device: Observational

Interventions

Observational DEVICE

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.

Observational

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy, non-smoking volunteers ages 18-50 years who meet inclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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 \[self-reported\]
• 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% \[measured by venous blood sample co-oximetry\]

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

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

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: September 3, 2024
• Study Start: October 21, 2024
• Primary Completion: March 20, 2025
• Study Completion: July 22, 2025
• Last Updated: July 25, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)