Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
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|ClinicalTrials.gov Identifier: NCT00705848|
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : March 21, 2017
|Condition or disease|
|Tracheobronchomalacia Tracheal Stenosis|
- 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 Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||April 2011|
|Actual Study Completion Date :||April 2011|
10 patients with tracheobronchomalacia
10 patients with tracheal stenosis
10 patients with normal airways (no known airway diseases)
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): NCT00705848
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Sidhu Gangadharan, M.D.||Beth Israel Deaconess Medical Center|