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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02488304 |
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Date of registration:
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26/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI)
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Scientific title:
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Prospective Study for Transplant Optimization Using Functional Imaging (TROFI) |
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Date of first enrolment:
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July 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02488304 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Wilfried De Backer, M.D., M.S. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Antwerp |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Male or female patient = 18 years old
- Written informed consent obtained
- Patients who are planned to receive a lung transplant in the near future
- Female patient of childbearing potential who confirm that a contraception method was
used at least 14 days before screening visit 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:
- Pregnant or lactating female
- Known history of or active airways or anastomotic complications requiring intervention
such as stenting or dilation
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bronchiolitis Obliterans
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Lung Transplant Rejection
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Intervention(s)
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Radiation: HRCT scans
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Primary Outcome(s)
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Change in Airway Volume (iVaw) using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Air trapping using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Internal Lobar Airflow Distribution using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Blood Vessel Density or Fibrosis Score using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Airway Resistance (iRaw) using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Specific Airway Volume (siVaw) using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Lobe Volumes (iVlobes) using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Specific Airway Resistance (siRaw) using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Airway Wall Thickness using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Change in Low Attenuation or Emphysema Score using FRI
[Time Frame: 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months post-transplant]
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Secondary ID(s)
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FLUI-2015-141
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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