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Clinical Trial Summary

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.


Clinical Trial Description

- Controlled pilot study to determine whether there exists, at a molecular level, a predisposition to the development of tracheomalacia and subglottic stenosis. Thirty patients will be divided into 2 groups of 20 patients (study patients) and 10 patients (control group). Both groups will undergo bronchoscopy and airway biopsy

- The study is a pilot study to evaluate alterations in the airway matrix, growth factor levels, and vascular structures.in patients with tracheobronchomalacia and subglottic stenosis

- Bronchoscopies will be performed in the West Procedure UnitPulmonary Special Procedures Unit or in the operating room (depending on the clinical indication and patient scheduling) at the BIDMC after informed consent is obtained.

- Patients will receive topical upper airway anesthesia with lidocaine and intravenous conscious sedation with fentanyl and midazolam as per standard of care

- Biopsies will be performed according to standard protocols.

- Biopsies will be performed: 2 samples will be sent for pathology as part of clinical care and 2-3 samples used for research analysis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00705848
Study type Observational
Source Beth Israel Deaconess Medical Center
Contact
Status Completed
Phase N/A
Start date July 2008
Completion date April 2011

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