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临床试验/NCT01580215
NCT01580215终止不适用

Long Term Follow up Investigation of Endobronchial Valves in Emphysema

Pulmonx International Sàrl1 个研究点 分布在 1 个国家目标入组 628 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
628
试验地点
1
主要终点
FEV1

研究概览

简要总结

This is an observational prospective single arm multicentre study to observe the effect over 5 years of Zephyr endobronchial valve therapy for emphysema.

详细描述

Primary objective is pulmonary function as assessed by FEV1 and secondary objectives are health related quality of life as assessed by the modified MRC dyspnea score and by the COPD assessment test, and survival at five years. 2000 patients will be enrolled in the study from approximately 200 referring centres in Germany. Patients will be followed up at 3, 6, and 12 months, and then yearly up to 5 years. The study will observe normal clinical practice. No investigations beyond those performed in normal clinical practice will be required with the exception of two short questionnaires. Patients will only be enrolled in the study if they have provided informed written consent for their anonymised data to be used in the study. Zephyr Endobronchial Valve has CE mark and is fully reimbursed in Germany and will not be provided by the sponsor for this study but will be obtained through normal commercial channels in accordance with normal clinical practice.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both genders of at least 18 years of age
  • Understand and voluntarily sign an informed consent form.
  • FEV1 > 15% predicted and < 45% predicted
  • RV >180% predicted
  • Diagnosis of emphysema with CT evidence of hyperinflation . Absence of collateral ventilation according to Chartis Assessment System

排除标准

  • Active pulmonary infection

结局指标

主要结局

FEV1

时间窗: 2 years

Relative (percentage) change from baseline at 2 years (24 months) of the Forced Expiratory Volume in one second (FEV1)

次要结局

  • Modified Medical Research Council (mMRC) Questionnaire(5 years)
  • Survival over 5 years(5 years)
  • COPD Assessment Test (CAT)(5 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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