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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