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INSPIRE Continuation Post-Approval Study

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 : Active, not recruiting
First Posted : March 11, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
TransMedics

Study Description
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Brief Summary:
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.

Condition or disease Intervention/treatment
Bronchiolitis Obliterans Device: OCS Lung System

Study Design
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Study Type : Observational
Estimated Enrollment : 300 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
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : June 1, 2024

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Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Brochiolitis Obliterans Syndrome (BOS) -free survival [ Time Frame: 5 years post transplant ]
    BOS-free survival


Secondary Outcome Measures :
  1. Survival [ Time Frame: 5 years ]
    Survival post transplant

  2. Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's) [ Time Frame: 5 years ]
    Freedom from BOS


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who participated in TransMedics OCS Lung System INSPIRE Trial
Criteria

Inclusion Criteria:

  • Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT03868904


Locations
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Sponsors and Collaborators
TransMedics
More Information
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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: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Bronchiolitis
Bronchiolitis Obliterans
Bronchitis
Bronchial Diseases
 Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections