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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
OCS Lung System
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
OCS Preservation
  • Device: OCS Lung Preservation
    OCS Lung Preservation
    Other names:
    • OCS Lung Transplant

More Details

Status
Terminated
Sponsor
TransMedics

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.