Wireless Lumee Oxygen Platform for PAD

Not currently recruiting at 2 trial locations

Overseen By Monica Lozano, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Profusa, Inc.

Disqualifiers: Active infection, Open wound, Keloids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study changes in tissue oxygen levels in individuals with Peripheral Artery Disease (PAD) using a new device called the Wireless Lumee Oxygen Platform. A small gel will be injected under participants' skin to track these oxygen changes, which are then sent to an app for monitoring. The research intends to evaluate the device's effectiveness compared to a standard oxygen measurement tool. Suitable candidates for this trial have stable PAD and have previously received treatment in their legs. Participants must commit to six visits over 12 months and agree to photos and videos of the study sites. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance PAD management.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Wireless Lumee Oxygen Platform is safe for monitoring tissue oxygen levels?

Research has shown that the Wireless Lumee Oxygen Platform safely monitors oxygen levels in tissue. A small sensor, injected under the skin, measures these levels. This sensor effectively detects changes in tissue oxygen in individuals with Peripheral Artery Disease (PAD).

Detailed reports of major side effects are absent. However, the device holds a CE mark, indicating it meets European safety standards and is generally well-tolerated. For concerns about safety or side effects, discussing them with the study team or your doctor may be beneficial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Wireless Lumee Oxygen Platform because it offers a new way to monitor tissue oxygen levels using a wireless system. Unlike traditional methods that rely on bulky and less convenient equipment like transcutaneous oxygen monitoring (TcPO2), the Lumee platform provides a more flexible and potentially more comfortable option for patients. This technology is expected to give more precise and real-time insights into how oxygen is delivered and utilized in the body, especially in areas like the arm and foot. By offering a non-invasive and continuous monitoring solution, it could significantly improve the management of conditions where tissue oxygenation is a concern.

What evidence suggests that the Wireless Lumee Oxygen Platform is effective for monitoring tissue oxygen levels in Peripheral Artery Disease?

Studies have shown that the Wireless Lumee Oxygen Platform, used by participants in this trial, effectively tracks changes in tissue oxygen levels. Research indicates that results from the Lumee platform closely match those from a TcPO2 device, another method for measuring tissue oxygen. Both methods reveal similar patterns when oxygen levels fluctuate. The Lumee system quickly detects these changes, proving reliable for monitoring oxygen in individuals with Peripheral Artery Disease (PAD). Initial findings suggest that the Lumee platform could enhance understanding of how oxygen levels change in the body. ^{1 5 6 7 8}

Who Is on the Research Team?

Monica M Lozano, PhD

Principal Investigator

Profusa, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with Peripheral Artery Disease (PAD) who are stable at enrollment, may have had prior lower extremity revascularization, and agree to the study's terms. Participants must be available for follow-up exams and understand that Lumee Oxygen hydrogels remain in tissue indefinitely.

Inclusion Criteria

Has been informed of the nature of the study, agrees to its provisions, and has signed the informed consent form prior to any study related procedure

Should plan to be available for all safety follow-up examinations at the investigational site

Is aware that the Lumee™ Oxygen hydrogels are intended to stay in the tissue indefinitely

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Hydrogel Insertion and Initial Monitoring

Initial insertion of the Lumee Oxygen hydrogel and monitoring of tissue oxygen levels

1-2 weeks

1 visit (in-person)

Ongoing Monitoring

Continuous monitoring of local tissue oxygen levels using the Wireless Lumee Oxygen Platform

12 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Wireless Lumee Oxygen Platform

Trial Overview The Wireless Lumee Oxygen Platform is being tested to monitor local tissue oxygen levels in PAD patients. The study involves a wireless device that reports oxygen levels using an injectable hydrogel and lasts for 12 months with six visits.

How Is the Trial Designed?

Group I: Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2 Experimental Treatment 1 Intervention

Monitoring local subcutaneous tissue oxygen dynamics using the Wireless Lumee Oxygen Platform in correlation to TcPO2 measurements in the arm and foot

Who Is Running the Clinical Trial?

Profusa, Inc.

Lead Sponsor

Trials

1

Recruited

50+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04514861

Monitoring Local Tissue Oxygen Changes Using the ... 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 ...

2. reporter.nih.gov reporter.nih.gov/search/np6GjSf7VUesMMuhv-m1xw/project-details/9752322

Tissue Oxygen Monitoring in Peripheral Vascular Disease We have met the goals of this project and successfully clinically verified the ability of Lumee Oxygen sensors to rapidly respond to local tissue oxygen changes ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04514861/monitoring-local-tissue-oxygen-changes-using-the-wireless-lumee-oxygen-platform-in-correlation-to-tcpo2

Monitoring Local Tissue Oxygen Changes Using the ... The Lumee Patch sends collected tissue oxygen data to the Lumee App which displays the collected data and operates up to four Lumee Patches.

4. evtoday.com evtoday.com/news/studies-presented-for-profusas-lumee-oxygen-platform-in-pad-patients

Studies Presented for Profusa's Lumee Oxygen Platform in ... The investigators found that there was a high correlation between the results of the Lumee platform and TcPO2, with both technologies showing a ...

5. drugdiscoverynews.com drugdiscoverynews.com/measuring-changes-in-tissue-oxygen-13051

Measuring changes in tissue oxygen Results revealed that the Lumee platform and tcpO2 were highly correlated, with both technologies showing a statistically significant decrease in oxygen levels ...

6. profusa.com profusa.com/profusa-receives-cemark/

Profusa Receives CE Mark Approval to Market the Wireless ... The data include changes in oxygen, comparison of current patient's data with historical data from a clinical registry study, and a data report.

7. nhlbi.nih.gov nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/small-business-program/sbir-success-stories/injectable-oxygen-sensor-could-improve-monitoring-peripheral-artery-disease

Injectable oxygen sensor could improve monitoring ... - NHLBI These tiny injectable sensors are capable of detecting tissue oxygen levels in patients with peripheral artery disease.

8. dicardiology.com dicardiology.com/content/lumee-oxygen-platform-measures-treatment-response-critical-limb-ischemia

Lumee Oxygen Platform Measures Treatment Response in ... Data reveal injectable monitor measures tissue oxygen level changes in response to standard-of-care procedures, showing potential to help ...