Ignite Creation Date:
2025-12-24 @ 1:06 PM
Ignite Modification Date:
2025-12-28 @ 9:12 PM
Study NCT ID:
NCT04514861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
Sponsor:
Profusa, Inc.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 4R44HL131366-02 | NIH | None | https://reporter.nih.gov/quic… | View |
| CFDA Number: 93.837 | OTHER | U.S. Department of Health and Human Services | View |