Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03868904




Registration number
NCT03868904
Ethics application status
Date submitted
7/03/2019
Date registered
11/03/2019
Date last updated
7/04/2022

Titles & IDs
Public title
INSPIRE Continuation Post-Approval Study
Scientific title
OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
Secondary ID [1] 0 0
OCS-LUN-03-PAS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis Obliterans 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - OCS Lung System

OCS Lung INSPIRE Trial -


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Brochiolitis Obliterans Syndrome (BOS) -free survival
Timepoint [1] 0 0
5 years post transplant
Secondary outcome [1] 0 0
Survival
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
Timepoint [2] 0 0
5 years

Eligibility
Key inclusion criteria
* Participant in TransMedics OCS Lung System INSPIRE trial
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* None

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/10/2021
Sample size
Target
Accrual to date
Final
220
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St. Vincent's Hospital - Darlinghurst
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Pennsylvania
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
France
State/province [9] 0 0
Strasbourg
Country [10] 0 0
Germany
State/province [10] 0 0
Berlin
Country [11] 0 0
Germany
State/province [11] 0 0
Hannover
Country [12] 0 0
Italy
State/province [12] 0 0
Padua
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Cambridge
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Middlesex

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
TransMedics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.
Trial website
https://clinicaltrials.gov/study/NCT03868904
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03868904