Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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. Identifier: NCT03868904
Recruitment Status : Completed
First Posted : March 11, 2019
Last Update Posted : April 7, 2022
Information provided by (Responsible Party):

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

Layout table for study information
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

Resource links provided by the National Library of Medicine

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.

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

Information from the National Library of Medicine

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.

Layout table for eligibility information
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

Inclusion Criteria:

  • Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion Criteria:

  • None

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 identifier (NCT number): NCT03868904

Show Show 17 study locations
Sponsors and Collaborators
Layout table for additonal information
Responsible Party: TransMedics 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

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