Skip to main content
OpenTrials
Completed

NCT Number: NCT03868904

INSPIRE Continuation Post-Approval Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bronchiolitis Obliterans Bronchial Diseases Bronchiolitis Bronchitis Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Vincent's Hospital, Darlinghurst, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant in TransMedics OCS Lung System INSPIRE trial

Exclusion criteria

  • None

Treatment and study plan

OCS Lung System

Device

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 outcomes

  1. Brochiolitis Obliterans Syndrome (BOS) -free survival

    Time frame: 5 years post transplant

    BOS-free survival

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2019
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.