Monitoring Local Tissue Oxygen Changes Using the Wireless Lumee Oxygen Platform in Correlation to TcPO2
NCT ID: NCT04514861
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
53 participants
INTERVENTIONAL
2020-12-18
2028-03-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2
Monitoring local subcutaneous tissue oxygen dynamics using the Wireless Lumee Oxygen Platform in correlation to TcPO2 measurements in the arm and foot
Wireless Lumee Oxygen Platform
The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue
Interventions
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Wireless Lumee Oxygen Platform
The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Profusa, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Monica M Lozano, PhD
Role: STUDY_DIRECTOR
Profusa, Inc.
Locations
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San Francisco General Hospital
San Francisco, California, United States
San Francisco Veterans Affairs Medical Center (SFVAMC)
San Francisco, California, United States
UCSF Medical Center
San Francisco, California, United States
Countries
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References
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Montero-Baker MF, Au-Yeung KY, Wisniewski NA, Gamsey S, Morelli-Alvarez L, Mills JL Sr, Campos M, Helton KL. The First-in-Man "Si Se Puede" Study for the use of micro-oxygen sensors (MOXYs) to determine dynamic relative oxygen indices in the feet of patients with limb-threatening ischemia during endovascular therapy. J Vasc Surg. 2015 Jun;61(6):1501-9.e1. doi: 10.1016/j.jvs.2014.12.060.
Chien JS, Mohammed M, Eldik H, Ibrahim MM, Martinez J, Nichols SP, Wisniewski N, Klitzman B. Injectable Phosphorescence-based Oxygen Biosensors Identify Post Ischemic Reactive Hyperoxia. Sci Rep. 2017 Aug 15;7(1):8255. doi: 10.1038/s41598-017-08490-0.
Wisniewski NA, Nichols SP, Gamsey SJ, Pullins S, Au-Yeung KY, Klitzman B, Helton KL. Tissue-Integrating Oxygen Sensors: Continuous Tracking of Tissue Hypoxia. Adv Exp Med Biol. 2017;977:377-383. doi: 10.1007/978-3-319-55231-6_49.
Nichols SP, Balaconis MK, Gant RM, Au-Yeung KY, Wisniewski NA. Long-Term In Vivo Oxygen Sensors for Peripheral Artery Disease Monitoring. Adv Exp Med Biol. 2018;1072:351-356. doi: 10.1007/978-3-319-91287-5_56.
Kanick SC, Schneider PA, Klitzman B, Wisniewski NA, Rebrin K. Continuous monitoring of interstitial tissue oxygen using subcutaneous oxygen microsensors: In vivo characterization in healthy volunteers. Microvasc Res. 2019 Jul;124:6-18. doi: 10.1016/j.mvr.2019.02.002. Epub 2019 Feb 8.
Other Identifiers
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CFDA Number: 93.837
Identifier Type: OTHER
Identifier Source: secondary_id
TP0139
Identifier Type: -
Identifier Source: org_study_id