Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2015-02-28
2017-01-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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HRCT scans
HRCT scan will be taken
High Resolution Computed Tomography scan
a HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5.
An Upper Airway (UA) scan will be taken on visit 1.
Interventions
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High Resolution Computed Tomography scan
a HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5.
An Upper Airway (UA) scan will be taken on visit 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent obtained
* Patient who had undergone a lung transplant a year ago or more.
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
* The patient must be able to perform the lung monitoring at home.
Exclusion Criteria
* Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation
18 Years
ALL
No
Sponsors
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FLUIDDA nv
INDUSTRY
Responsible Party
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Principal Investigators
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David Lederer, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
James Lee, M.D., M.S.
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Columbia University Medical Center
New York, New York, United States
Hospital of the University of Pennsylvania
Gibson, Pennsylvania, United States
Countries
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Other Identifiers
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FLUI-2014-103_USA
Identifier Type: -
Identifier Source: org_study_id
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