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.
Brief Title
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
OCS Lung System
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04194398
Org Class
Industry
Org Full Name
TransMedics
Org Study Id
OCS-LUN-122018
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
Primary Outcomes
Outcome Description
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Outcome Measure
Patient and graft survival
Outcome Time Frame
2 years
Outcome Description
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Outcome Measure
Patient and graft survival
Outcome Time Frame
3 years
Outcome Description
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Outcome Measure
Patient and graft survival
Outcome Time Frame
4 years
Outcome Description
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Outcome Measure
Patient and graft survival
Outcome Time Frame
5 years
Outcome Description
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Outcome Measure
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Outcome Time Frame
2 years
Outcome Description
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Outcome Measure
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Outcome Time Frame
3 years
Outcome Description
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Outcome Measure
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Outcome Time Frame
4 years
Outcome Description
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Outcome Measure
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Outcome Time Frame
5 years
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Stephen Forest
Investigator Email
sforest@montefiore.org