INSPIRE Continuation Post-Approval Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03868904 |
Recruitment Status :
Completed
First Posted : March 11, 2019
Last Update Posted : April 7, 2022
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Condition or disease | Intervention/treatment |
---|---|
Bronchiolitis Obliterans | Device: OCS Lung System |
Study Type : | Observational |
Actual Enrollment : | 220 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS |
Actual Study Start Date : | June 30, 2019 |
Actual Primary Completion Date : | October 12, 2021 |
Actual Study Completion Date : | October 12, 2021 |

Group/Cohort | Intervention/treatment |
---|---|
OCS Lung INSPIRE Trial |
Device: OCS Lung System
No active interventions are part of this study. This study will collect long-term survival and BOS data in subjects who were part of the INSPIRE trial. |
- Brochiolitis Obliterans Syndrome (BOS) -free survival [ Time Frame: 5 years post transplant ]BOS-free survival
- Survival [ Time Frame: 5 years ]Survival post transplant
- Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's) [ Time Frame: 5 years ]Freedom from BOS

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Participant in TransMedics OCS Lung System INSPIRE trial
Exclusion Criteria:
- None

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): NCT03868904

Responsible Party: | TransMedics |
ClinicalTrials.gov Identifier: | NCT03868904 |
Other Study ID Numbers: |
OCS-LUN-03-PAS |
First Posted: | March 11, 2019 Key Record Dates |
Last Update Posted: | April 7, 2022 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Bronchiolitis Bronchiolitis Obliterans Bronchitis Respiratory Tract Infections Infections |
Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |