Zephyr Etude Post-Inscription (French Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 12
- 主要终点
- Forced Expiratory Volume in 1 second (FEV1)
研究概览
简要总结
The objective of this Registry is to provide ongoing safety and effectiveness assessment of the Zephyr Valve treatment of adult patients with Chronic Obstructive Pulmonary Disease (COPD) Grade III and Grade IV in order to support the renewal of the inscription of the Zephyr Valve on the list LPPR (Art 165-1) in France.
详细描述
This is a multi-center, single-arm, prospective Registry to be conducted at a minimum of 12 study centers. Approximately 150 patients with severe emphysema undergoing Zephyr Valve treatment will be enrolled and followed out to 3 years. Assessments will be performed at 45-days, 6-months, 12-months, 24-months and 36-months post-procedure.
Patients prescribed the Zephyr Valve treatment will be consented and will be enrolled only after determination of little to no collateral ventilation between target and ipsilateral lobes. Safety and effectiveness of the Zephyr Valve treatment will be evaluated post-treatment based on data collected out to 3-years post-treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with emphysema (COPD Grade III and Grade IV) considered appropriate for the bronchoscopic lung volume reduction procedure by the physician.
- •Subjects who signed an Informed Consent Form to allow data collection.
排除标准
- •Subjects determined to have collateral ventilation between the target(s) and ipsilateral lobe(s).
研究组 & 干预措施
Zephyr Valve treatment
Patients undergoing the Zephyr Valve treatment for emphysema/COPD
干预措施: Zephyr Valve (Device)
结局指标
主要结局
Forced Expiratory Volume in 1 second (FEV1)
时间窗: 12 months
The percent of patients achieving an improvement in the post-bronchodilator FEV1 of ≥12% at 12-months.
次要结局
- Treated Lobar Volume Reduction (TLVR)(45 days)