NCT07166341

Accuracy Verification of the INVOS PM7100

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 48 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 46 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Verify that the INVOS PM7100 system in conjunction with the INVOS Adult Sensors meets the requirements for tissue saturation accuracy.

Conditions

• Tissue Oxygenation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-09-29
• Primary completion: 2025-12-23
• Completion: 2026-04-24
• First posted: 2025-09-10
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study