NCT04514861

Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2

Effectiveness of Measuring Local Tissue Oxygen in Response to Induced Hemodynamic Changes With the Profusa's Wireless Lumee Oxygen Platform in Patients With Peripheral Artery Disease (PAD)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Profusa, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to monitor changes in local tissue oxygen levels in participants with Peripheral Artery Disease (PAD) using the Wireless Lumee Oxygen Platform. A transcutaneous oxygen pressure (TcPO2) device is used to show correlations in oxygen dynamics. Oxygen dynamics are induced by a pressure cuff and position maneuvers. Study participants will participate in the study for 12 months with six (6) planned visits over the course of the study. The investigational device, the Wireless Lumee Oxygen Platform, consists of the Lumee Oxygen, a sterile soft injectable oxygen-sensitive hydrogel, designed to sense and report oxygen levels in the subcutaneous tissue. After initial insertion of the hydrogel in the subcutaneous tissue using the Lumee Pen (a sterile disposable injector device), tissue oxygen levels can be monitored continuously using the Lumee Patch (a non-invasive, non-sterile, wireless electronic device to collect, analyze and report tissue oxygen levels sensed by Lumee Oxygen Hydrogel) attached to the skin through the Lumee Patch Adhesive (designed to adhere the Lumee Patch). The Lumee Patch sends collected tissue oxygen data to the Lumee App which displays the collected data and operates up to four Lumee Patches.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Wireless Lumee Oxygen Platform	The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue

Timeline

• Start date: 2020-12-18
• Primary completion: 2027-03-30
• Completion: 2028-03-30
• First posted: 2020-08-17
• Last updated: 2025-11-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study