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ACTIVE NOT RECRUITING
NCT07166341

Accuracy Verification of the INVOS PM7100

Sponsor: Medtronic - MITG

View on ClinicalTrials.gov

Summary

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

Official title: Accuracy Performance Verification of the INVOS™ PM7100 System, Comparing rSO2 Values to Reference Blood Oxygen Saturation Measurements in Adult Human Volunteers

Key Details

Gender

All

Age Range

18 Years - 46 Years

Study Type

OBSERVATIONAL

Enrollment

48

Start Date

2025-09-29

Completion Date

2026-04-24

Last Updated

2026-01-13

Healthy Volunteers

Yes

Interventions

DEVICE

Observational

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States