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Trial record 1 of 1 for:    NCT03343535
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Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation (EXPAND LUNG II)

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ClinicalTrials.gov Identifier: NCT03343535
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
TransMedics

Brief Summary:
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Condition or disease Intervention/treatment Phase
Lung Transplantation Device: OCS Lung Preservation Not Applicable

Detailed Description:

Inclusion

At least one of the following:

  • Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
  • Expected cross-clamp time > 6 hours for the second lung; or
  • Donor after Cardiac Death (DCD donor); or
  • Donor age ≥ 55 years old

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Intervention Model Description: OCS Lung System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
Actual Study Start Date : March 12, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCS
OCS Lung Preservation
Device: OCS Lung Preservation
OCS Lung Preservation
Other Name: OCS Lung Transplant




Primary Outcome Measures :
  1. Patient Survival [ Time Frame: 30 days post transplantation ]
    Patient survival at Day-30 post-transplantation and at initial hospital discharge post-transplantation, whichever occurs later.

  2. Donor Lung Utilization Rate [ Time Frame: Immediately at Transplantation ]
    Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.


Secondary Outcome Measures :
  1. Primary Graft Dysfunction Grade 3 [ Time Frame: within 72 hours pos-transplant ]
    Incidence of Primary Graft Dysfunction Grade 3 on post-operative day 3



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female primary double lung transplant candidate
  • Age ≥ 18 years old
  • Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

Exclusion Criteria:

  • Prior solid organ or bone marrow transplant
  • Single lung recipient
  • Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
  • Participant in any other clinical or investigational trials/programs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343535


Contacts
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Contact: Amira H Hassanein, MD, PhD 978-552-0900 ext 0972 ahassanein@transmedics.com
Contact: Tamer I Khayal, MD 978-552-0900 ext 0902 tkhayal@transmedics.com

Locations
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United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Michael A. Smith, MD    602-406-4000    Michael.Smith011@DignityHealth.org   
Principal Investigator: Michael A Smith, MD         
United States, California
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Contact: Abbas Ardehali, MD    310-825-5841    aardehali@mednet.ucla.edu   
Principal Investigator: Abbas Ardehali, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Joy Chen       joy.chen@ucsf.edu   
Principal Investigator: Jasleen Kukreja, MD         
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Rachelle Villanueva       rvilla@stanford.edu   
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Errol L Bush, MD    410-614-3891    errol.bush@jhmi.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Mauricio Villavicencio, MD    617-726-5608    MVillavicencio@mgh.harvard.edu   
Principal Investigator: Mauricio Villavicencio, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Stephen Huddleston, MD    612-625-8698    Huddl007@umn.edu   
Principal Investigator: Stephen Huddleston, MD         
United States, Nebraska
University of Nebraska Recruiting
Omaha, Nebraska, United States, 68198
Contact: Aleem Siddique, MD       aleem.siddique@unmc.edu   
Principal Investigator: Aleem Siddique, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Matthew Hartwig, MD, MHS    919-613-5635    matthew.hartwig@duke.edu   
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Yoshiya Toyoda, MD, PhD    215-707-7692    yoshiya.toyoda@tuhs.temple.edu   
United States, Texas
Baylor St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Gabriel Loor, MD    832-355-3000    gabriel.loor@bcm.edu   
Houston Methodist Recruiting
Houston, Texas, United States, 77030
Contact: Ahmed O Gaber, MD    713-441-5451    AOGaber@houstonmethodist.org   
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Alexander Krupnick, MD         
Contact       ak2yf@hscmail.mcc.virginia.edu   
Principal Investigator: Alexander Krupnick, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Lucian A Durham, MD, PhD       ldurham@mcw.edu   
Principal Investigator: Lucian A Durham, MD, PhD         
Sponsors and Collaborators
TransMedics

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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT03343535     History of Changes
Other Study ID Numbers: OCS-LUN-012017
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by TransMedics:
portable ex-vivo lung perfusion
breathing lung transplant
portable OCS Lung System