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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: Wireless Lumee Oxygen Platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A suitable candidate must meet the following criteria: Male or female must be ≥ 18 years of age Diagnosed with PAD, stable at time of enrollment, and may include prior stable lower extremity revascularization 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 Is aware that photos of injection sites and wound site will be taken, and videos may be recorded Exclusion Criteria: A candidate will be excluded from the study if any of the following criteria are met: PAD of Rutherford Classification 5 or 6 at time of enrollment Subject has an active infection Subject has an open wound on limb included in study Known history of keloids, excessive fibrosis during wound healing Known allergies to Lumee™ Oxygen hydrogel components, local anesthetic agents, suture materials, or severe skin allergies to adhesives Any skin or musculoskeletal condition or deformity limiting injection of the Lumee™ Oxygen hydrogel or preventing subsequent attachments of the Lumee™ Patch system Any skin modification in the area of injection that would potentially influence device performance (for example tattoos or scars) Previous amputation proximal to the digital level on the limb included in the study Significant venous insufficiency resulting in swelling of the lower leg, ankle or foot or chronic venous stasis changes (CEAP clinical score ≥ 3) Any condition that at the discretion of the investigator, physician or designee will impact the safety of the subject or the scientific integrity of the trial Female subjects of childbearing capacity (not surgically sterile or menopausal for ≥ 1 year) Participation in another clinical study, that would potentially interfere with the participation in this study Subject requires dialysis Subject is immunocompromised Subject has incompressible arteries tested by occlusion test in the arm Inability to obtain consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Single-arm, non-randomized, effectiveness and performance study with confirmatory device in subjects with PAD
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2<br>Monitoring local subcutaneous tissue oxygen dynamics using the Wireless Lumee Oxygen Platform in correlation to TcPO2 measurements in the arm and foot | Device: Wireless Lumee Oxygen Platform<br>* The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the arm | 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. | At 2 days (±1 day) after injection and at 3 months (±14 days) after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the foot | 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 foot during changes of oxygen induced by pressure cuff. | 1-14 days after hydrogel insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peripheral Arterial Disease, Tissue Oxygen Monitoring, TcPO2