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Accuracy Verification of the INVOS PM7100

NCT07166341 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2026-05-14

No results posted yet for this study

Summary

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

Conditions

  • Tissue Oxygenation

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.

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • David MacLeod, MDDS · Duke University

Eligibility

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

Timeline & Regulatory

Start
2025-09-29
Primary Completion
2025-12-23
Completion
2026-04-23
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 NCT07166341 on ClinicalTrials.gov