OCS Lung System
DevicePatients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.
Completed
NCT Number: NCT04194398
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Hospitals Leuven, Leuven, Belgium
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About this study
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.
Who can participate
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
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Patient and graft survival
Time frame: 2 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
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Patient and graft survival
Time frame: 3 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
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Patient and graft survival
Time frame: 4 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
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Patient and graft survival
Time frame: 5 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)
Time frame: 2 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
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Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 3 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
-
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 4 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
-
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 5 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Sponsors and collaborators
Lead sponsor
TransMedics
Industry
Registry information
Important dates
- Study start
- 2018
- Primary completion
- 2021
- Study completion
- 2021
- First posted
- Dec 11, 2019
- Registry last updated
- Apr 7, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.