NCT01102712已完成不适用
Evaluation Study of Unilateral Bronchoscopic Thermal Vapor Ablation (BTVA) in Patients With Heterogeneous Emphysema and Upper Lobe Predominance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 20
- 主要终点
- increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points
研究概览
简要总结
To establish and confirm the safety and clinical utility of BTVA applied unilaterally for lung volume reduction in patients with upper lobe predominate heterogeneous severe emphysema.
详细描述
All subjects meeting the eligibility criteria and who provide written informed consent will be enrolled. 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; pulmonary hypertension; indwelling pacemaker or implantable cardiac defibrillator (ICD); pregnancy or breastfeeding
结局指标
主要结局
increase in FEV1 ≥ 12% or a decrease in total St. George's Respiratory Questionnaire (SGRQ) score ≥ 4 points
时间窗: 6 months
次要结局
- Lobar volume reduction as determined by computed tomography (CT) analysis(3 months)
- Changes in pulmonary function therapy(3 months)
- Improvement in 6 minute walk distance(3 months)
研究者
研究点 (20)
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