Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
This study has been completed.
Information provided by:
Beth Israel Deaconess Medical Center
First received: June 24, 2008
Last updated: June 13, 2011
Last verified: June 2011
It is not clearly understood what causes tracheobronchomalacia (weakening of the windpipe and airways) or tracheal stenosis (narrowing of the windpipe). We plan to take biopsies (small pieces of tissue) and brushings (to collect the cells that form the lining of the airway) from the airways of patients with these diseases and analyze these samples in a laboratory to try and determine the mechanism of disease. We will compare the results with that of patients with normal airways.
||Observational Model: Case Control
Time Perspective: Prospective
||Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
Biospecimen Retention: Samples With DNA
Airway biopsies and brushings are to be used for staining and culture, respectively
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
10 patients with tracheobronchomalacia
10 patients with tracheal stenosis
10 patients with normal airways (no known airway diseases)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients with tracheobronchomalacia or tracheal stenosis referred to this tertiary care facility
- (study group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, prior bronchoscopic diagnosis of tracheobronchomalacia, prior bronchoscopic diagnosis of subglottic stenosis (either idiopathic or post-intubation), and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.
- (control group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, no prior diagnosis of any airway disease of any etiology, and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure.
- (study group): pre-existing airway disorders other than tracheobronchomalacia or subglottic stenosis, etiology of subglottic stenosis other than idiopathic or post-intubation, pulmonary vascular disease, inability to tolerate intravenous conscious sedation.
- (control group): any pre-existing airway disorder, pulmonary vascular disease, and inability to tolerate intravenous conscious sedation.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00705848
|Beth Israel Deaconess Medical Center
|Boston, Massachusetts, United States, 02215 |
Beth Israel Deaconess Medical Center
||Sidhu Gangadharan, M.D.
||Beth Israel Deaconess Medical Center
No publications provided
||Sidhu Gangadharan, M.D., Beth Israel Deaconess Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 24, 2008
||June 13, 2011
||United States: Institutional Review Board
Keywords provided by Beth Israel Deaconess Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 23, 2014
Pathological Conditions, Anatomical
Respiratory Tract Diseases
Connective Tissue Diseases