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OCS Lung System EXPAND II Trial | Clinical Trials | Clareo Health

TERMINATEDNA

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

NCT03343535•TransMedics

View on ClinicalTrials.gov

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.

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (14)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

UCLA Medical Center

Los Angeles, California, United States

University of California, San Francisco

San Francisco, California, United States

Stanford University Medical Center

Stanford, California, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Nebraska

Omaha, Nebraska, United States

Duke University Medical Center

Durham, North Carolina, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

March 12, 2018

Primary Completion Date

August 27, 2019

Completion Date

July 6, 2022

Last Updated

February 28, 2024

Enrollment

ACTUAL participants

Conditions

Lung Transplantation

Interventions

OCS Lung Preservation

DEVICE

Trifecta-Lung cfDNA-MMDx Study

NCT05837663

Lung Transplantation

View study

RECRUITING

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

NCT07291258

Solid Organ TransplantationPregnancy+11 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

OCS Lung System EXPAND II Trial

Inclusion Criteria

Exclusion Criteria

Trifecta-Lung cfDNA-MMDx Study

Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation

Risk Factors That Increase the Chance of Developing Primary Graft Dysfunction After Lung Transplantation

LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.

The Effect of Perioperative Factors on Postoperative Outcomes After Lung Transplantation

Sleep-disordered Breathing After Solid Organ Transplantation