US Pilot Safety and Feasibility Study of Bronchoscopic Thermal Vapor Ablation (BTVA) for Lung Volume Reduction in Patients With Heterogeneous Emphysema With Upper Lobe Predominance
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
To assess the safety and efficacy of BTVA for the treatment of patients with heterogeneous upper lobe emphysema.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: > 40 and ≤ 75 years old
- •Diagnosis of heterogeneous emphysema with upper lobe predominance
- •FEV1 < 45% predicted
- •TLC > 100% predicted
- •RV > 150% predicted
- •6-minute walk test > 140 meters
- •mMRC ≥ 2 (mMRC)
- •Non-smoking for 3 months
- •Optimized medical management and completed pulmonary rehabilitation
排除标准
- •Known α-1-antitrypsin deficiency
- •BMI < 15 kg/m2 or > 35 kg / m2
- •History of pneumothorax within previous 18 months
- •History of heart and / or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, and/or lobectomy
- •Respiratory infections or recurring COPD exacerbations > 3 hospitalizations in past 12 months or active infection
- •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
结局指标
主要结局
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
时间窗: 6 months
次要结局
- Radiographic evidence of lung volume reduction (assessed by study site radiologist) and CT scan (assessed by blinded radiologist at CT core lab)(6 months)