Tracheobronchomalacia: Treatment Outcomes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00550602|
Recruitment Status : Completed
First Posted : October 30, 2007
Last Update Posted : February 3, 2017
|Condition or disease|
TBM is an abnormal collapse of the tracheal and bronchial walls. It is characterized by flaccidity of the supporting tracheal and bronchial structures and a significant reduction of airway diameter on expiration seen in the trachea and/or in the mainstem bronchi. Currently there is no available data on the efficacy of central airway stabilization for treating TBM.
Our study would provide this important information and would establish the effect of central airway stabilization on symptoms, functional status, quality of life, lung function and exercise capacity in patients with symptomatic and severe TBM.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Tracheobronchomalacia: Treatment Outcomes|
|Study Start Date :||January 2002|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||March 2010|
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00550602
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center- Division of Interventional Pulmonology|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Armin Ernst, M.D. FCCP||Beth Israel Deaconess Medical Center|