INSPIRE Continuation Post-Approval Study

April 6, 2022 updated by: TransMedics

OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS

To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital
  • Belgium
      • Leuven, Belgium, 3000
        • University of Leuven Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
  • France
      • Strasbourg, France, 67091
        • N.H.C Hospital Civil
  • Germany
      • Berlin, Germany, D-13353
        • German Heart Institute Berlin
      • Hannover, Germany, D-300625
        • Hannover Medical School
  • Italy
      • Padua, Italy, 35128
        • University of Padua
  • Spain
      • Madrid, Spain, 25222
        • Hospital Universitario Puerta de Hierro
  • United Kingdom
      • Cambridge, United Kingdom, CB23 3RE
        • Papworth Hospital
      • Middlesex, United Kingdom, UB9 6JH
        • Harefield Hospital
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • St. Joseph's Hospital and Medical Center
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • San Francisco, California, United States, 94143
        • University of California at San Francisco
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who participated in TransMedics OCS Lung System INSPIRE Trial

Description

Inclusion Criteria:

  • Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brochiolitis Obliterans Syndrome (BOS) -free survival
Time Frame: 5 years post transplant
BOS-free survival
5 years post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 5 years
Survival post transplant
5 years
Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
Time Frame: 5 years
Freedom from BOS
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TransMedics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2019

Primary Completion (Actual)

October 12, 2021

Study Completion (Actual)

October 12, 2021

Study Registration Dates

First Submitted

March 7, 2019

First Submitted That Met QC Criteria

March 7, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCS-LUN-03-PAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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