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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 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.

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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.

Conditions Studied

Peripheral Artery Disease

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

FieldValue
Enrollment Target 53 participants
Start Date 2020-12-18
Est. Completion 2028-03-30
Phase NA

Sponsor

Profusa

1 total trials

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What the Registry Record Tells You About NCT04514861

The ClinicalTrials.gov registry entry for NCT04514861 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 126-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (58% lower). The listed sponsor is Profusa, which has 1 total studies on file at ClinicalTrials.gov.

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 3 study locations spanning 1 distinct geographic area - top geographies include 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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.