OCS Lung System
Conditions
Brief summary
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
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.
Interventions
DEVICEOCS Lung System
Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.
Sponsors
TransMedics
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient and graft survival | 2 years | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. |
| Presence or absence of bronchiolitis obliterans sydrome (BOS) | 2 years | Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider. |
Countries
Belgium, Germany, United States
Outcome results
None listed