NCT02022683已完成不适用
A Multi-center, Prospective, Randomized, Controlled Trial of Endobronchial Valve Therapy vs. Standard of Care in Heterogeneous Emphysema
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 34
- 主要终点
- Forced Expiratory Volume in 1-second (FEV1) - Responders
研究概览
简要总结
To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obtained informed consent.
- •Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
- •Subjects of both genders of at least 40 years of age.
- •15 % predicted ≤ FEV1≤ 45% predicted.
- •TLC > 100% and RV ≥ 180% predicted.
- •150 meters < 6MWD < 450 meters.
- •Non-smoker >8 weeks prior to signing the Informed Consent.
- •CV negative target lobe.
- •Additional inclusion criterion French CIP*:
- •If treated in France, Subject must be entitled to French social security
排除标准
- •Any contraindication for bronchoscopic procedure.
- •Evidence of active pulmonary infection.
- •History of 2 or more exacerbations requiring hospitalization over the past 12 months.
- •Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
- •Myocardial infarction or other relevant cardiovascular events in the past 6 months.
- •Significant bronchiectasis seen at CT scan.
- •Greater than two tablespoons of sputum production per day.
- •Prior LVR or LVRS procedure. Criterion 8 French CIP wording*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy).
- •Pulmonary nodule requiring follow-up within any lobe.
- •Pregnant or nursing women. French CIP wording*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
- •Hypercapnia (paCO2 > 7.33 kPa).
- •Current diagnosis of asthma.
- •> 25mg Prednisolon (or equivalent) use/days.
- •Any other condition that as judged by the investigator may make follow-up or investigations inappropriate.
- •Evidence of pleural adhesions or earlier pulmonary surgery.
- •Severe Bullous Emphysema (> 1/3 Hemithorax)
- •Any subject that according to the Declaration of Helsinki is unsuitable for enrollment.
- •Additional exclusion criteria in the French CIP*:
- •History of allergy to silicone and/or nitinol.
- •If treated in France, Subject is a "personne vulnerable" as defined by French regulation.
- •Simultaneous participation in another drug and/or medical device related clinical.
结局指标
主要结局
Forced Expiratory Volume in 1-second (FEV1) - Responders
时间窗: Between baseline and 3 months
The percentage of trial participants in the EBV treatment arm meeting the minimally clinically important difference (MCID) of \>12% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 3 months post-procedure.
次要结局
- St George's Respiratory Questionnaire (SGRQ) - Absolute change(Between Baseline and 3, 6, 12, 18 and 24 months)
- St George's Respiratory Questionnaire (SGRQ) - Percent change(Between Baseline and 3, 6, 12, 18 and 24 months)
- 6-minute walk distance (6MWT) - Absolute change(Between Baseline and 3, 6, 12, 18, 24 months)
- 6-minute walk distance (6MWT) - Responders(Between Baseline and 3, 6, 12, 18, 24 months)
- Forced Expiratory Volume in 1-second (FEV1) - Responders(Between Baseline and 3, 6, 12, 18, 24 months)
- Target Lobar Volume Reduction (TLVR) - Absolute change(Between baseline and 45 days)
- St George's Respiratory Questionnaire (SGRQ) - Responders(Between Baseline and 3, 6, 12, 18 and 24 months)
- 6-minute walk distance (6MWT) - Percent change(Between Baseline and 3, 6, 12, 18, 24 months)
- Forced Expiratory Volume in 1-second (FEV1) - Absolute change(Between Baseline and 3, 6, 12, 18, 24 months)
- Forced Expiratory Volume in 1-second (FEV1) - Percent change(Between Baseline and 6, 12, 18 and 24 months)
- mMRC (Modified Medical Research Council) score - Responders(Between Baseline and 3, 6, 12, 18 and 24 months)
- Target Lobar Volume Reduction (TLVR) - Responders(Between baseline and 45 days)
- Target Lobar Volume Reduction (TLVR) - Percent change(Between baseline and 45 days)
研究者
研究点 (34)
Loading locations...
相似试验
Unknown
不适用
Endobronchial Valve in Patients With Heterogeneous EmphysemaChronic Obstructive Pulmonary DiseaseEmphysemaNCT02823223Chinese PLA General Hospital72
已完成
不适用
ELVR in PH Patients With Severe EmphysemaCOPDPulmonary EmphysemaNCT01393379Heidelberg University10
Unknown
不适用
Lung Volume Reduction Via Coils in Patients With COPDChronic Obstructive Pulmonary Disease (COPD)NCT02246569RWTH Aachen University20
终止
不适用
Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) StudyEmphysemaNCT01608490Boston Scientific Corporation315
Unknown
不适用
Emphysematous Lung Sealant Therapy in Homogeneous EmphysemaPatients With Advanced Homogeneous EmphysemaNCT01728662Rabin Medical Center8