Status:
COMPLETED
Accuracy Performance Verification of the INVOS™ PM7100 System in Adults
Lead Sponsor:
Medtronic - MITG
Conditions:
Oxygen Saturation
Eligibility:
All Genders
18-50 years
Brief Summary
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-invas...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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% \[measured by venous blood sample co-oximetry\]
Key Trial Info
Start Date :
October 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 22 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06581835
Start Date
October 21 2024
End Date
July 22 2025
Last Update
July 25 2025
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27705