NL-OMON56894招募中不适用
Bronchoscopic Release of Air Trapped in Hyperinflated Emphysematous Lung - BREATHE-2 study
Medical Devices company - Apreo Health Inc.0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 35 and <= 80 years old 2. Computed tomography (CT) scan evidence of
- •homogeneous or heterogeneous emphysema 3. At least one target lobe with > 35%
- •destruction (percent of voxels with < -950 Hounsfield units on CT) 4.
- •Post-bronchodilator ratio of FEV1/FVC < 0.7 at screening 5. Post-bronchodilator
- •FEV1 percent predicted >=15% and <=50% of predicted at screening 6.
- •Post-bronchodilator RV > 180% predicted 7. Post-bronchodilator RV/TLC >= 0.55 at
- •screening 8. Marked dyspnea, scoring >= 2 on the modified Medical Research
- •Council scale of 0-4 9. Cotinine testing at screening indicates nonsmoker and
- •stopped smoking at least 8 weeks before entering the trial and agrees to
- •refrain from smoking for duration of study participation 10. Fully vaccinated
- •for Covid-19 and has current pneumococcus and influenza vaccination (or
- •documented clinical intolerance) 11. Cognitively and physically able to provide
- •written informed consent and complete participant questionnaires
排除标准
- •1. Arterial blood PaCO2 > 60 mmHg (8 kPa) or PaO2 <= 45 mmHg (6 kPa) 2. DCLO
- •<20% at screening 3. Steroid therapy of 10 mg prednisolone (prednisone) or more
- •per day 4. Three or more acute exacerbations of COPD in the past year before
- •enrollment 5. Two or more hospitalizations for acute exacerbations of COPD or
- •respiratory infections in the past year before enrollment 6. Any acute
- •exacerbation of COPD or respiratory infection less than 4 weeks before the
- •first Apreo Procedure 7. Previous lung volume reduction surgery or lobectomy,
- •segmentectomy or bullectomy, vapor, glue, or other pulmonary device implant 8.
- •Known history of pulmonary arterial hypertension 9. Presence of a giant bulla
- •(>= 30% of hemithorax) 10. History of excessive dynamic airway collapse of the
- •trachea or main bronchi 11. History of adult asthma or chronic bronchitis 12.
- •Presence of suspicious pulmonary nodule/infiltrate that requires additional
- •follow-up, diagnostics or treatment 13. Unequivocal and symptomatic
- •bronchiectasis 14. Unequivocal lung cancer or other current cancer diagnosis
- •except non-metastasized basal cell skin cancer 15. Uncontrolled hypertension
- •(blood pressure that is inadequately treated or resistant to treatment) with a
- •systolic > 200 mmHg or diastolic > 110 mmHg at screening or prior to first
- •Apreo Procedure 16. Uncorrectable coagulopathy or other condition likely to
- •increase risk of peri- or post- Apreo Procedure bleeding 17. On anticoagulant
- •or antiplatelet therapy and unable or unwilling to hold for Apreo Procedure 18.
- •Coronary artery disease with angina 19. History of myocardial infarction within
- •6 months 20. History of a stroke less than 1 year before the first Apreo
- •Procedure 21. Clinical history of heart failure with documented LVEF <= 40% 22.
- •Clinical history of diabetes with a HbA1c > 9.0% 23. Estimated glomerular
- •filtration rate (eGFR) <30 mL/min/1.73m2 (CKD-EPI) OR participant with kidney
- •failure (Stage 5 kidney disease)
研究者
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