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Accuracy Performance Verification of the INVOS™ PM7100 System in Adults

NCT06581835 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 42

Last updated 2025-07-25

No results posted yet for this study

Summary

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

Conditions

  • Oxygen Saturation

Interventions

DEVICE

Observational

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.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-21
Primary Completion
2025-03-20
Completion
2025-07-22
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06581835 on ClinicalTrials.gov