View Clinical Trial (Medical Research Study)

Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction - NCT01041586-(Clinical Trial 463936)



ClinicalConnection.com has recently undergone an update and this page may no longer be up-to-date. Please Search For Clinical Trials to view the most current clinical trials listings.


Signup
City:  Seattle
State:  
WA
Zip Code:
Conditions: Emphysema - Chronic Obstructive Pulmonary Disease
Purpose: To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.
Study summary: All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. Immediately prior to BTVA treatment, an initial bronchoscopy will be performed to evaluate the baseline condition of the airways and to confirm anatomy of the lung segments targeted for BTVA treatment. Up to 3 segments in either the right or left upper lobe will be treated with a vapor dose of 10 calories per gram of lung tissue (10 cal/g). Targeted lobe for treatment will be based on lobar disease severity.
Criteria: Inclusion Criteria: 1. Age: > 40 and ≤ 75 years old 2. Diagnosis of heterogeneous emphysema with upper lobe predominance 3. FEV1 < 45% predicted 4. TLC > 100% predicted 5. RV > 150% predicted 6. 6-minute walk test > 140 meters 7. mMRC ≥ 2 (mMRC) 8. Non-smoking for 3 months 9. Optimized medical management and completed pulmonary rehabilitation Exclusion Criteria: 1. Known α-1-antitrypsin deficiency 2. BMI < 15 kg/m2 or > 35 kg / m2 3. History of pneumothorax within previous 18 months 4. History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy 5. Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection 6. History of the (EF) ≤ 40%; Stroke; Unstable Myocardial Ischemia; FEV1 < 15% predicted; DLCO < 20% predicted; of pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
Trials Alerts: If you would like to be notified of new clinical trials as they become available please register for a free account.
Data Source: ClinicalTrials.gov
Date Processed: August 3, 2010
Modifications to
this listing:		 Only selected fields are shown, please use the link above to view all information about this clinical trial.