Accuracy Verification of the INVOS PM7100 (NCT07166341) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Accuracy Verification of the INVOS PM7100
United States48 participantsStarted 2025-09-29
Plain-language summary
Prospective, observational, pre-market, verification study to confirm accuracy of the INVOS 7100 system in compliance with ISO 80601-2-85:2021 standard
Who can participate
Age range18 Years – 46 Years
SexALL
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Inclusion Criteria:
* 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%
Exclusion Criteria:
* 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…
What they're measuring
1
Accuracy in terms of the root mean square error
Timeframe: Performance evaluation is expected take approximately 2.5 hours