emphysema
Conditions
Interventions
study device and drug:device and drug
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patient between 20 to 80 years old; 2. High Resolution CT scan indicates homogeneous or heterogeneous emphysema; 3. Patient has post- bronchodilator FEV1 less than or equal to 45% of predicted; 4. Total Lung Capacity > 100% of predicted; 5. Residual volume >= 200% of predicted; 6. Patient has marked dyspnea scoring > 2 on mMRC scale of 0-4; 7. Patient has been given optimal care and had been stable for 3 months prior to baseline. Patient has completed a pulmonary rehab within 3 months if applicable; 8. Patient (and legal guardian if applicable) to read, understood and signed the Informed Consent form.
Exclusion criteria
Exclusion criteria: 1. Patient has a change in FEV1 > 20% post-bronchodilator. 2. Patient has an inability to walk >100 meters in 6 minutes. 3. Patient has an inability to tolerate bronchoscopy 4. Patients cannot tolerate general anesthesia 5. Patient has not quit smoking or had not quit smoking for less than 6 months prior to study initiation (determined based on COHb 1/3 lung volume 9. Patient with Chronic obstructive pulmonary disease (COPD) characterized by excessive sputum and obvious thickening of bronchial wall. 10. Patient has had previous LVR surgery, lung transplant or lobectomyor has still ELVR devices or other device to treat 11. Patient has a history of recurrent clinically significant respiratory infection, defined as with 3 and more hospital stays in the past 12 months. 12. Patient with a disease history of asthma, cystic fibrosis, interstitial lung disease (ILD),active tuberculosis,lung damage, lung cancer, and central airway stenosis 13. Patient with pleural effusion and/or pneumothorax 14. Patient with moderate or severe exacerbation of chronic obstructive pulmonary disease (COPD) within 3 months or is in the acute exacerbation of COPD (moderate exacerbation of COPD defined as: An acute event with the need of antibiotic treatment or oral glucocorticoid treatment, severe exacerbation of COPD defined as: An acute event with the need of hospitalization or emergency or intensive care unit treatment) 15. Patient is taking > 10mg prednisone (or similar steroid) daily. assessments or that would adversely affect outcomes. 16. Patient with a known allergy to nitinol,silicone, gold, platinum, stainless steel. 17. BMI > 35 kg/m2 or BMI 55 mm Hg, PaO2 50mmHg and/or with pulmonary artery widening or right ventricular enlargement evidence. 21. Patient with obvious pleural adhesion, tuberculous pleurisy, chest wall malformation, and had undergone pleural fixation or other thoracotomy. 22. Patient life expectancy is less than 3 years 23. Patient has evidence of any other disease that may compromise survival (such as severe malnutrition, Alzheimer's disease, lung cancer or other advanced tumors, severe organ dysfunction, unstable angina, heart failure, any other investigator identified such evidences.) 24. Patient with high risk of aspiration (cerebrovascular sequelae, pseudobulbar palsy, etc.) identified by investigator 25. Pregnancy, or planned pregnancy by patient or her spouse at the time of the study, or failure to use reliable contraception 26. Patient has been involved in other clinical studies within 3 months without completion or withdraw prior to this study screening period. 27. Patient not suitable for device implantation determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1; | — |
Countries
China
Contacts
Public ContactWill Wei
henzhen Xianjian Respiratory Technology Co., Ltd
Outcome results
None listed