Clinical trial NCT04194398: OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
Official title: OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OCS Lung System
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2019-12-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.

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.

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

Primary outcomes:
measure: Patient and graft survival
timeFrame: 2 years
measure: Patient and graft survival
timeFrame: 3 years
measure: Patient and graft survival
timeFrame: 4 years
measure: Patient and graft survival
timeFrame: 5 years
measure: Presence or absence of bronchiolitis obliterans sydrome (BOS)
timeFrame: 2 years
measure: Presence or absence of bronchiolitis obliterans sydrome (BOS)
timeFrame: 3 years
measure: Presence or absence of bronchiolitis obliterans sydrome (BOS)
timeFrame: 4 years
measure: Presence or absence of bronchiolitis obliterans sydrome (BOS)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Leuven
country: Belgium
facility: Hospitals Leuven
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
References: