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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00550602 |
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Date of registration:
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26/10/2007 |
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Primary sponsor: |
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Public title:
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Tracheobronchomalacia: Treatment Outcomes
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Scientific title:
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Tracheobronchomalacia: Treatment Outcomes |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00550602 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Armin Ernst, M.D. FCCP |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beth Israel Deaconess Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Suspicion of symptomatic tracheal and/or bronchial collapse during bronchoscopy or
Dynamic Computed Tomographic study.
- Chronic Obstructive Pulmonary Disease (regardless of severity) and suspicion of
tracheal and/or bronchial collapse
Exclusion Criteria:
- inability to follow commands
- Focal extrinsic compression of the trachea/bronchi by mass or other
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tracheobronchomalacia
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Tracheomalacia
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Primary Outcome(s)
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To evaluate the effect of central airway stabilization on symptoms and quality of life in patients with symptomatic and severe tracheobronchomalacia.
[Time Frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty]
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Secondary Outcome(s)
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To evaluate the effect of central airway stabilization on lung function, exercise capacity and functional status.
[Time Frame: At 10-14 days post-stent ; at 3 months and yearly post-tracheobronchoplasty]
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Secondary ID(s)
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2005P-000112
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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