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NCT03868904 Clinical Trial

INSPIRE Continuation Post-Approval Study

Bronchiolitis Obliterans Clinical Trial

Official title:
OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03868904
Other study ID # OCS-LUN-03-PAS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2019
Est. completion date October 12, 2021

Study information
Verified date November 2021
Source TransMedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 220
Est. completion date October 12, 2021
Est. primary completion date October 12, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Participant in TransMedics OCS Lung System INSPIRE trial Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Australia St. Vincent's Hospital Darlinghurst New South Wales
Belgium University of Leuven Hospital Leuven
Canada University of Alberta Edmonton Alberta
France N.H.C Hospital Civil Strasbourg
Germany German Heart Institute Berlin Berlin
Germany Hannover Medical School Hannover
Italy University of Padua Padua
Spain Hospital Universitario Puerta De Hierro Madrid
United Kingdom Papworth Hospital Cambridge
United Kingdom Harefield Hospital Middlesex
United States Massachusetts General Hospital Boston Massachusetts
United States Indiana University Indianapolis Indiana
United States UCLA Medical Center Los Angeles California
United States University of Minnesota Minneapolis Minnesota
United States St. Joseph's Hospital and Medical Center Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States University of California at San Francisco San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
TransMedics

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Brochiolitis Obliterans Syndrome (BOS) -free survival BOS-free survival 5 years post transplant
Secondary Survival Survival post transplant 5 years
Secondary Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's) Freedom from BOS 5 years
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