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

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TERMINATEDNANCT03343535

OCS Lung System EXPAND II Trial

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 transplanta...

Lead sponsor: TransMedics•14 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

TransMedics

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 28, 2024Terms

Trial snapshot

StatusTERMINATED

PhaseNA

Enrollment46

Start dateMar 2018

Last updatedFeb 28, 2024

Condition

Lung Transplantation

Locations shown

St. Joseph's Hospital and Medical Center

Phoenix, Arizona

UCLA Medical Center

Los Angeles, California

University of California, San Francisco

San Francisco, California

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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: May 10, 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.

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