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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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Scientific title
OCS Lung INSPIRE Long-Term Continuation Post-Approval Study - INSPIRE Continuation PAS
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Secondary ID [1]
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OCS-LUN-03-PAS
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis Obliterans
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Brochiolitis Obliterans Syndrome (BOS) -free survival
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Assessment method [1]
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BOS-free survival
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Timepoint [1]
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5 years post transplant
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Secondary outcome [1]
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Survival
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Assessment method [1]
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Survival post transplant
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Timepoint [1]
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5 years
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Secondary outcome [2]
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Freedom from Bronchiolitis Obliterans Syndrome (BOS) as determined from pulmonary function tests (PFT's)
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Assessment method [2]
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Freedom from BOS
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Timepoint [2]
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5 years
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Eligibility
Key inclusion criteria
- Participant in TransMedics OCS Lung System INSPIRE trial
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- None
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/06/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/10/2021
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Sample size
Target
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Accrual to date
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Final
220
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Indiana
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United States of America
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Massachusetts
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United States of America
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Minnesota
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United States of America
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Pennsylvania
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Belgium
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Leuven
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Canada
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Alberta
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Hannover
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Italy
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Padua
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Spain
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Madrid
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United Kingdom
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State/province [14]
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Cambridge
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Country [15]
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United Kingdom
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State/province [15]
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Middlesex
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
TransMedics
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
To evaluate long-term BOS-free survival outcomes of the OCS™ Lung INSPIRE Trial patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03868904
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03868904
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