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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 (OCS EXPAND II)

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ClinicalTrials.gov Identifier: NCT03343535
Recruitment Status : Enrolling by invitation
First Posted : November 17, 2017
Last Update Posted : June 15, 2018
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

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



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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


Locations
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
United States, Texas
Baylor St. Luke's Medical Center
Houston, Texas, United States, 77030
Houston Methodist
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
TransMedics

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 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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