Chronic Obstructive Pulmonary Disease, Emphysema
Conditions
Keywords
Emphysema, COPD, Lung Volume Reduction, BTVA
Brief summary
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.
Detailed description
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.
Interventions
DEVICEBTVA System
Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
Sponsors
Uptake Medical Corp
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurence of adverse events (serious and non-serious) secondary to the BTVA treatment procedure from initiation of treatment through completion of the six-month follow-up period | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab) | 6 months |
Countries
United States
Outcome results
None listed