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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03343535
Other study ID # OCS-LUN-012017
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 12, 2018
Est. completion date July 6, 2022

Study information

Verified date November 2023
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 46
Est. completion date July 6, 2022
Est. primary completion date August 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OCS Lung Preservation
OCS Lung Preservation

Locations

Country Name City State
United States The Johns Hopkins Hospital Baltimore Maryland
United States Massachusetts General Hospital Boston Massachusetts
United States University of Virginia Charlottesville Virginia
United States Duke University Medical Center Durham North Carolina
United States Baylor St. Luke's Medical Center Houston Texas
United States Houston Methodist Houston Texas
United States UCLA Medical Center Los Angeles California
United States Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States University of Nebraska Omaha Nebraska
United States Temple University Hospital Philadelphia Pennsylvania
United States St. Joseph's Hospital and Medical Center Phoenix Arizona
United States University of California, San Francisco San Francisco California
United States Stanford University Medical Center Stanford California

Sponsors (1)

Lead Sponsor Collaborator
TransMedics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of Lung Graft-related Serious Adverse Events Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject. 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Primary 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
Primary 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 Primary Graft Dysfunction Grade 3 Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours 72 hours post-transplant
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