Bronchoscopic Lung Volume Reduction Treatment in Clinical Practice: Introduction and Implementation in The Netherlands and Evaluation of a National Database
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Quality of treatment
研究概览
简要总结
Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.
Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.
详细描述
Rationale: New bronchoscopic treatments for emphysema have shown promise in clinical trials, improving lung function, exercise capacity and possibly survival and are now being adopted by a number of centres in the Netherlands. It is important to ensure that the benefits seen in clinical trials are in fact reflected in clinical practice and that the best use of this early 'real world' experience is made to optimise the development and use of these novel therapies.
Overall objective: to develop a national database to record bronchoscopic lung volume reduction procedures for patients with emphysema. This is desirable for audit purposes but will also be an important resource for research both in gathering data and in facilitating collaborations.
Study design: This study is a nationwide, multicenter, observational post-marketing study with long-term follow up (5 years).
Study population: The study population exists of patients with severe emphysema who undergo a bronchoscopic lung volume reduction treatment with one-way endobronchial valves.
Main study parameters/endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Quality of treatment
时间窗: Baseline-30 days
Quality will be assessed by a High resolution CT check at 30 day post-treatment of the placement of the valves.
次要结局
- Change from baseline in exercise capacity at 5 years follow up after treatment.(Baseline- 5 years)
- Change from baseline in health status at 5 years follow up after treatment.(Baseline- 5 years)
- Change from baseline in lungfunction at 5 years follow up after treatment.(Baseline- 5 years)
- The incidence of a pneumothorax after the treatment until 5 years follow up.(Baseline- 5 year)
- Change from baseline in breathlessness at 5 years follow up after treatment.(Baseline- 5 years)
研究者
Dirk-Jan Slebos
MD PhD
University Medical Center Groningen