OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

Study Overview
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Brief Summary
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Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.

Detailed Description
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The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.

Official Title
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OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

Conditions
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OCS Lung System

Intervention / Treatment
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* Device: OCS Lung System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Registered 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 diagnosis of chronic renal insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OCS Expand Trial Cohort<br>All patients previously enrolled in the EXPAND Lung trial. | Device: OCS Lung System<br>* Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 2 years | 
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 3 years | 
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 4 years | 
| Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 5 years | 
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 2 years | 
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 3 years | 
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 4 years | 
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. | 5 years |