OCS Lung System Clinical Trial
Official title:
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
Verified date | February 2022 |
Source | TransMedics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 79 |
Est. completion date | September 30, 2021 |
Est. primary completion date | September 30, 2021 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Hospitals Leuven | Leuven | |
Germany | Hannover Medical School | Hannover | |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Duke University Medical Center | Durham | North Carolina |
United States | University of California at Los Angeles | Los Angeles | California |
United States | University of Minnesota | Minneapolis | Minnesota |
United States | St. Joseph's Hospital and Medical Center | Phoenix | Arizona |
United States | University of California at San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
TransMedics |
United States, Belgium, Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 2 years | |
Primary | Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 3 years | |
Primary | Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 4 years | |
Primary | Patient and graft survival | Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider. | 5 years | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |