Study Stopped
Enrollment in EXPAND II was stopped June 24, 2019 as a result of the FDA approval for the EXPAND indication. Therefore, no additional sites or subjects were enrolled after that time.
OCS Lung System EXPAND II Trial
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
1 other identifier
interventional
46
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 6, 2022
CompletedResults Posted
Study results publicly available
February 28, 2024
CompletedFebruary 28, 2024
November 1, 2023
1.5 years
November 8, 2017
December 19, 2023
February 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Patient Survival
Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.
30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Donor Lung Utilization Rate
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.
Immediately at Transplantation
Secondary Outcomes (1)
Primary Graft Dysfunction Grade 3
72 hours post-transplant
Other Outcomes (1)
Number of Lung Graft-related Serious Adverse Events
30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Study Arms (1)
OCS Preservation
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TransMedicslead
Study Sites (14)
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
UCLA Medical Center
Los Angeles, California, 90095, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Stanford University Medical Center
Stanford, California, 94305, United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Baylor St. Luke's Medical Center
Houston, Texas, 77030, United States
Houston Methodist
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Results Point of Contact
- Title
- VP, Clinical Affairs
- Organization
- TransMedics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2017
First Posted
November 17, 2017
Study Start
March 12, 2018
Primary Completion
August 27, 2019
Study Completion
July 6, 2022
Last Updated
February 28, 2024
Results First Posted
February 28, 2024
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share