NCT03360396已完成不适用
A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 19
- 主要终点
- Absolute Change in SGRQ Score at 6 Months
研究概览
简要总结
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.
详细描述
This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Read, understood and signed the Informed Consent form
- •Meets indications for use per the IFU
- •Bilateral heterogeneous and/or homogeneous emphysema
- •Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted
- •Post bronchodilator Residual Volume (RV) ≥ 200% predicted
- •Post bronchodilator Total Lung Capacity (TLC) >100% pred.
- •Post bronchodilator RV/TLC > 55%
- •Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
- •Receiving optimal drug therapy and medical management according to clinical practice.
- •Performing regular physical activity, at least 2 times per week
- •Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
- •100m ≤ 6 minute walk distance (6MWD) ≤ 450m
- •Deemed eligible per Eligibility Review Committee (ERC)
- •if treated in France, subject must be entitled to French social security.
排除标准
- •Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated
- •Evidence of active infection in the lungs
- •Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals
- •Clinical significant pulmonary fibrosis
- •Clinically significant, generalized bronchiectasis
- •Clinically significant bleeding disorders
- •Patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection).
- •Primary diagnosis of asthma
- •Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations .
- •Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
- •Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
- •Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease
- •Severe bullous disease (defined by bulla > 8cm or 1/3 of lung volume, or single bullous defect >8 cm) or predominant paraseptal emphysema [defined by numerous large (>1cm) paraseptal defects in the target lobe comprising of >5% of total lung volume].
- •Lung pathology of nodule not proven stable or benign
- •Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant
- •Use of more than 20 mg/day prednisolone or equivalent dosage of a different corticosteroid
- •Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
- •Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
- •Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
- •Diagnosed with alpha-1 antitrypsin deficiency
- •Diffusion Capacity of the lungs for Carbon Monoxide (DLCO) < 20 %
- •Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
- •Body Mass Index (BMI) > 30
- •Participation in any other clinical Study.
- •Subject is pregnant or lactating, or plan to become pregnant within the study timeframe.
- •If treated in France, Subject is a "personnel vulnerable" as defined by French Regulation
研究组 & 干预措施
Endobronchial Coils
Experimental
Treatment with PneumRx Endobronchial Coil System
干预措施: Endobronchial Coils (Device)
Control
No Intervention
Medically-managed control group
结局指标
主要结局
Absolute Change in SGRQ Score at 6 Months
时间窗: 6 months
Change in SGRQ score - St. George Respiratory Questionnaire from 0 to 100, higher score indicating more limitations (worse), increase in score indicating worse outcome, decrease in score indicating improvement
Percent Change in FEV1 at 6 Months
时间窗: 6 months
Percent change in FEV1
次要结局
未报告次要终点
研究者
研究点 (19)
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