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

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ClinicalTrials.gov Identifier: NCT04514861

Recruitment Status : Recruiting

First Posted : August 17, 2020

Last Update Posted : September 20, 2021

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View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

National Institutes of Health (NIH)

National Heart, Lung, and Blood Institute (NHLBI)

Information provided by (Responsible Party):

Profusa, Inc.

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Recruiting
Estimated Primary Completion Date :	December 2021
Estimated Study Completion Date :	May 2022

Publications:

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.