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



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 75
Updated:1/17/2019
Start Date:March 12, 2018
End Date:December 31, 2022
Contact:Amira H Hassanein, MD, PhD
Email:ahassanein@transmedics.com
Phone:978-552-0900

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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.

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

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
We found this trial at
12
sites
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Phone: 650-736-2042
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Stanford, CA
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Mauricio Villavicencio, MD
Phone: 617-726-5608
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Boston, MA
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Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Stephen Huddleston, MD
Phone: 612-625-8698
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Phone: 410-614-3891
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Baltimore, MD
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Alexander Krupnick, MD
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Phone: 919-613-5635
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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Houston, Texas 77030
Phone: 832-355-3000
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Houston, TX
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Houston, Texas 77030
Phone: 713-441-5451
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Houston, TX
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
Principal Investigator: Abbas Ardehali, MD
Phone: 310-825-5841
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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Los Angeles, CA
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3401 N Broad St
Philadelphia, Pennsylvania
(215) 707-2000
Phone: 215-707-7692
Temple University Hospital On January 18, 1892 a three-story house at 3403 North Broad Street...
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Philadelphia, PA
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
Principal Investigator: Michael A Smith, MD
Phone: 602-406-4000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Phoenix, AZ
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San Francisco, California 94143
Principal Investigator: Jasleen Kukreja, MD
Phone: 415-353-4145
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San Francisco, CA
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