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

Primary Purpose

Peripheral Artery Disease

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Wireless Lumee Oxygen Platform

About this trial

This is an interventional basic science trial for Peripheral Artery Disease focused on measuring Peripheral Arterial Disease, Tissue Oxygen Monitoring, TcPO2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

San Francisco General HospitalRecruiting
San Francisco Veterans Affairs Medical Center (SFVAMC)Recruiting
UCSF Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT04514861

First Posted

July 27, 2020

Last Updated

September 16, 2021

Sponsor

Profusa, Inc.

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04514861

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 18, 2020 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Profusa, Inc.

Collaborators

National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease

Keywords

Peripheral Arterial Disease, Tissue Oxygen Monitoring, TcPO2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-arm, non-randomized, effectiveness and performance study with confirmatory device in subjects with PAD

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tissue Oxygen Dynamics with Lumee Oxygen and TcPO2

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Wireless Lumee Oxygen Platform

Intervention Description

The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue

Primary Outcome Measure Information:

Title

Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the arm

Description

Time Frame

At 2 days (±1 day) after injection and at 3 months (±14 days) after injection

Secondary Outcome Measure Information:

Title

Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the foot

Description

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.

Time Frame

1-14 days after hydrogel insertion

Other Pre-specified Outcome Measures:

Title

Correlation of subcutaneous oxygen dynamics measured by the Wireless Lumee Oxygen Platform and a TcPO2 device in the arm and foot

Description

Correlation of measurements between subcutaneous tissue oxygen concentrations expressed by the unitless Lumee Oxygen Index (LOI; measured by the Wireless Lumee Oxygen Platform) and transcutaneous partial pressure of oxygen (TcPO2; measured by the Periflux System 5000 or Periflux System 6000) in arm and foot during changes of oxygen induced by pressure cuff and positional maneuvers at various timepoints.

Time Frame

Throughout 12 months.

Title

Occurrence of Adverse Events

Time Frame

Throughout 12 months and during all unscheduled visits

Title

Lumee™ Patch and Lumee™ Oxygen hydrogel placement site skin observations

Description

Skin observations will follow a grading system for Erythema, Edema and Hematoma at the injection site and the skin area where the Lumee Patches were adhered. The scores rank from 0= No Edema/Erythema/Hematoma, 1= very slight, 2 = well-defined, 3=moderate to 4= severe. Incidences of these ranks will we analyzed.

Time Frame

Throughout 12 months and during all unscheduled visits

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Taylor Noriega, PharmD

Phone

415.655.9861

taylor.noriega@profusa.com

First Name & Middle Initial & Last Name or Official Title & Degree

Monica Lozano, PhD

Phone

415.655.9861

monica.lozano@profusa.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kerstin Rebrin, MD, PhD

Organizational Affiliation

Profusa, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

San Francisco General Hospital

City

San Francisco

State/Province

California

ZIP/Postal Code

94110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Menke, PhD

Phone

415-353-4368

laura.menke@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Shant Vartanian, MD

Facility Name

San Francisco Veterans Affairs Medical Center (SFVAMC)

City

San Francisco

State/Province

California

ZIP/Postal Code

94121

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Cheng

Phone

415-221-4810

Ext

24708

david.cheng4@va.gov

First Name & Middle Initial & Last Name & Degree

James C Iannuzzi, MD

Facility Name

UCSF Medical Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Menke, PhD

Phone

415-353-4368

laura.menke@ucsf.edu

First Name & Middle Initial & Last Name & Degree

Michael S Conte, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26004327

Citation

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.

Results Reference

background

PubMed Identifier

28811566

Citation

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.

Results Reference

background

PubMed Identifier

28685468

Citation

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.

Results Reference

background

PubMed Identifier

30178370

Citation

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.

Results Reference

background

PubMed Identifier

30742844

Citation

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.

Results Reference

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

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