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NCT04514861 · ClinicalTrials.gov registry record · NA
Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
A NA study of Peripheral Artery Disease, sponsored by Profusa.
- Active
- Registry status
- NA
- Development phase
- 53
- Enrollment target
- 3
- Study locations
NCT04514861: Active NA study of Peripheral Artery Disease, sponsored by Profusa.
NCT04514861 is a NA study of Peripheral Artery Disease that is active but no longer recruiting, run by Profusa. The registered enrollment target is 53 participants, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (58% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04514861, a NA study of Peripheral Artery Disease, is active but no longer recruiting, sponsored by Profusa.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
Correlation of measurements between subcutaneous tissue oxygen concentration expressed by the Lumee Oxygen Index (LOI; unitless; measured by the Wireless Lumee Oxygen Platform) and transcutaneous partial pressure of oxygen (TcPO2; mmHg; measured by the Periflux System 5000 or Periflux System 6000) in the arm during changes of oxygen induced by pressure cuff.
Conditions Studied
Interventions
- DEVICE Wireless Lumee Oxygen Platform
Study Locations (3)
California
- San Francisco General Hospital - San Francisco
- San Francisco Veterans Affairs Medical Center (SFVAMC) - San Francisco
- UCSF Medical Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2028-03-30 |
| Phase | NA |
What the registry record for NCT04514861 still lists
NCT04514861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Peripheral Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Wireless Lumee Oxygen Platform is the first listed.
NCT04514861 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04514861 about?
NCT04514861 is a clinical study titled "Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2". 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...
What is the current status of trial NCT04514861?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 53 participants. The study started on 2020-12-18. Estimated completion is 2028-03-30.
What conditions does trial NCT04514861 study?
This clinical trial studies the following conditions: Peripheral Artery Disease.
What interventions are being tested in trial NCT04514861?
The interventions under investigation include: Wireless Lumee Oxygen Platform (DEVICE).
Who is sponsoring clinical trial NCT04514861?
This trial is sponsored by Profusa, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04514861 being conducted?
This trial has 3 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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