NL-OMON42867已完成不适用
A Multicenter, Prospective, Single-Arm Clinical Investigation of a Modified Staged Treatment Algorithm using the AeriSeal system - STAGE trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
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 64（—）
入选标准
- •1. Subject is willing and able to provide informed consent and to participate in the study.
- •2. Subject is >= 40 years of age.
- •3. Subject has a diagnosis of homogenous or heterogeneous upper lobe predominant emphysema confirmed by CT scan.
- •4. Subject has at least 2 non-adjacent subsegments appropriate for treatment based upon CT scan in 2 different upper lobe segments in each lung (total 4 available subsegments)
- •5. Subject has clinically significant dyspnea scoring >= 1 on the mMRC scale of 0 - 4
- •6. Subject has a Six-Minute Walk Test (6MWT) distance >= 250 meters
- •7. Subject has post-bronchodilator FEV1 <= 45% predicted
- •8. Subject has Total Lung Capacity >100% predicted
- •9. Subject has Residual Volume >= 175% predicted
- •10. Subject has stopped smoking for at least 8 weeks prior to entering the study as confirmed by carboxyhemoglobin or cotinine levels.
- •11. Subject has received preventive vaccinations against potential respiratory infections consistent with local recommendations or policy.
排除标准
- •1. Subject has severe bullous emphysema as judged by the Investigator.
- •2. Subject has prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
- •3. Subject has evidence of active respiratory infection
- •4. Subject has an ongoing COPD exacerbation or bronchospasm
- •5. Subject has a known allergy to the device components:
- •a. Polyether block amide - PEBAX®
- •b. Polyvinyl Alcohol
- •c. Glutaraldehyde
- •6. Subject requires ventilatory support (invasive or non-invasive)
- •7. Subject has DLco < 20% predicted
- •8. Subject has a post-bronchodilator FEV1 < 20% predicted
- •9. Subject cannot tolerate corticosteroids or relevant antibiotics
- •10. Subject has other relevant comorbidities as judged by the Investigator, or is deconditioned and cannot tolerate the stress of post-treatment inflammatory response;
- •11. Subject has a history of recurrent clinically significant respiratory infections, defined as three (3) or more COPD exacerbations requiring hospitalization during the year prior to enrollment.
- •12. Subject has severe gas exchange abnormalities as defined by any one of the following:
- •a. PaCO2 >55 mm Hg
- •b. PaO2 <45 mm Hg on room air
- •c. SpO2 < 90% on >= 4 L/min supplemental O2, at rest
- •13. Subject has Pulmonary hypertension, defined as peak systolic pressure > 45 mm Hg on echocardiogram or right heart catheterization.
- •14. Subject use of systemic steroids > 20 mg/day or equivalent, immunosuppressive agents, heparins, oral anticoagulants (e.g., warfarin, dicumarol; note: antiplatelet drugs including aspirin and clopidogrel are permitted) within 4 weeks of entering the study.
- •15. Subject has alpha1 -antitrypsin serum level of <80 mg/kg (i.e. < 11 µmol/L) at Screening
- •16. Subject*s CT scan indicates the presence of any the following radiologic abnormalities:
- •a. Pulmonary nodule on CT scan greater than 0.8 cm in diameter (Does not apply if present for 2 years or more without increase in size or if proven benign by biopsy/PET)
- •b. Radiologic picture consistent with active pulmonary infection, e.g., unexplained parenchymal infiltrate
- •c. Significant interstitial lung disease
- •d. Significant pleural disease
- •17. Subject*s baseline EKG indicates arrhythmias or conduction abnormalities.
- •18. Subject has high cardiac risk after undergoing cardiac risk assessment in accordance with published guidelines or ischemic heart disease, congestive heart failure, renal failure or cerebrovascular disease :
- •19. Clinically significant asthma (reversible airway obstruction), chronic bronchitis, or bronchiectasis.
- •20. Allergy or sensitivity to medications required to safely perform bronchoscopy and the AeriSeal System treatment under general anesthesia or conscious sedation.
- •21. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to entering the study or planned during the course of the study.
- •22. Body mass index (BMI) < 15 kg/m2 or > 35 kg/m2
- •23. Female subject pregnant or breast-feeding.
- •24. Abnormal screening laboratory test results as compared to reference lab normals at individual sites as follows:
- •a. Blood urea nitrogen > 1.5 x upper limit of normal
- •b. Creatinine > 1.5 x upper limit of normal
- •c. Aspartate aminotransf
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