Bronchoscopic Conversion of Collateral Ventilation in CV-positive Emphysema Patients Before Endobronchial Valve Treatment - Mind The Gap Crossing Borders Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- feasibility - Target Lobar Volume Change on Chest -CT scan
研究概览
简要总结
Rationale: A big step forward and great opportunity to improve overall efficacy of bronchoscopic lung volume reductioen is to combine treatment modalities aiming to close the dependent collateral channels and then proceed with EBV therapy to induce lobar collapse, and thus maximal treatment effect.
Objective:
Primary objective:
- To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
Secondary objectives: 2. To investigate the safety of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment. 3. To investigate the effectiveness of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Diagnosis of emphysema with a treatable target for endobronchial valves (Zephyr).
- •Subjects of both genders of at least 35 years of age at the time of the baseline visit.
- •Understand and voluntarily sign a patient informed consent form.
- •15 % predicted ≤ FEV1 ≤ 50% predicted.
- •RV ≥ 175% predicted, and TLC ≥ 100% predicted and RV/TLC ≥ 55%.
- •6MWD ≥ 140 meters.
- •Dyspnea score of ≥2 on the mMRC scale of 0-
- •Non-smoker > 6 months prior to signing the informed consent.
- •Chartis CV positive between target and ipsilateral lobe
排除标准
- •Evidence of active pulmonary infection.
- •Evidence of clinically significant bronchiectasis.
- •History of more than 3 exacerbations with hospitalizations over the past 12 months.
- •Myocardial infarction or other relevant cardiovascular events in the past 6 months.
- •Prior lung surgery, Lung volume reduction surgery, lung transplantation, lobectomy, or pneumonectomy.
- •Prior endoscopic lung volume reduction.
- •Unstable pulmonary nodule requiring follow-up
- •Pregnant of nursing women.
- •Hypercapnia defined by PaCO2 > 8.0kPa, or Hypoxemia defined by PaO2 < 6.0kPa, both measured on room air.
- •Any disease with high probability of mortality within 24 months.
- •Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins), which cannot be stopped periprocedural.
- •Patient was involved in other pulmonary drug studies within 30 days prior to this study.
结局指标
主要结局
feasibility - Target Lobar Volume Change on Chest -CT scan
时间窗: 3 months
To investigate the feasibility of injecting AeriSeal into the interlobar collateral ventilation channels region to make the target lobe suitable for endobronchial valve treatment
次要结局
- effectiveness - Measurement of change in Forced Expiratory Volume in one second (FEV1).(3 months)
- effectiveness - Measurement of change in Residual Volume (RV)(3 months)
- safety - Number and specification of reported (S)AEs per individual patient and as aggregate(3 months)
- changes in Quality of Life as measured by the SGRQ(3 months)
- effectiveness - Measurement of changes in 6-minute walk test (6MWT)(3 months)
- changes in Quality of Life as measured by the COPD Assessment Test (CAT)(3 months)
研究者
Dirk-Jan Slebos
Prof. dr. D.J. Slebos MD, PhD
University Medical Center Groningen