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OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection

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ClinicalTrials.gov Identifier: NCT04194398
Recruitment Status : Active, not recruiting
First Posted : December 11, 2019
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
TransMedics

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.

Condition or disease Intervention/treatment
OCS Lung System Device: 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.

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
Actual Study Start Date : December 31, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Group/Cohort Intervention/treatment
OCS Expand Trial Cohort
All patients previously enrolled in the EXPAND Lung trial.
Device: OCS Lung System
Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194398


Locations
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United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California at San Francisco
San Francisco, California, United States, 94143
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Belgium
Hospitals Leuven
Leuven, Belgium, 3000
Germany
Hannover Medical School
Hannover, Germany, D-300625
Sponsors and Collaborators
TransMedics
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Responsible Party: TransMedics
ClinicalTrials.gov Identifier: NCT04194398    
Other Study ID Numbers: OCS-LUN-122018
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes