Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Experimental group: received pulse ablation surgery and standard treatment (refer to GOLD guideline recommended standard treatment):The treatment of pulsed ablation means that a pulsed ablation cathet
Control group: received simulated surgery and standard treatment (refer to GOLD guideline recommended standard treatment):Simulated surgical procedures will be performed by one-time use of a pulsed ab
Sponsors
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. 35 years old =30% of the estimated value; 4. Meet one of the following conditions: (1). The sum of answers to the first two questions of CAT >=7 points, and the total score of CAT >=10 points; (2). The sum of the answers to the first two questions of CAT is 6 points, and the total score of CAT is > 20 points; 5. SGRQ score >=25; 6. Received standard drug therapy in line with the guideline recommendation within the past 1 year, and the standard drug therapy regimen has lasted for more than or equal to 8 weeks, and the disease control is not ideal; 7. If you have a history of smoking, quit smoking (cigarettes, e-cigarettes, etc.) for at least 3 months before enrollment, and agree not to smoke during the study period; 8. Be able to understand the purpose of the experiment, voluntarily participate and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Known unsolved lower respiratory tract infections (e.g., pneumonia, Mycobacterium avium intra infection (MAI), fungi, tuberculosis); 2. Have a steroid-dependent disease that requires oral corticosteroids >10 mg daily; 3. There are any implantable electronic devices (such as pacemakers, cardioverter defibrillators) that cannot be turned off during surgery; 4. A history of untreated arrhythmia within the past two years; 5. Have uncured lung cancer; 6. There is a lung nodule or cavity and intervention is expected to be required during the study; 7. Prior lung surgery such as lung transplantation, pulmonary valve transplantation, lobectomy, lung implants/prostheses, metal airway stents, valves, coils, or bullostectomy (excluding prior pneumothorax without pulmonary resection, non-surgical pleural treatment, or segmental lung tissue resection); 8. Quantitative HRCT scan (low attenuation area less than -950HU), emphysema greater than or equal to 50%; 9. Diagnosed with asthma; 10. Clinically significant bronchiectasis, affecting the clinical symptoms of cough and sputum; 11. The 6-minute walking test is less than 225 meters; 12. Uncontrolled gastroesophageal reflux disease; 13. Acute ischemic heart disease or cardiac insufficiency (left ventricular ejection fraction (LVEF) 50mmHg as measured by echocardiography); 15. Combined with respiratory failure (arterial partial oxygen pressure (PaO2) less than 8kPa (60mmHg), or accompanied by carbon dioxide (PaCO2) more than 6.65kPa (50mmHg), namely respiratory failure); 16. COPD acute exacerbation stage; 17. Severe airway stenosis, which is impossible to perform bronchoscopy, or airway stenosis caused by extrinsic tumor/enlarged lymph node compression; 18. Intrabronchial diffuse hemorrhage; 19. Known contraindications to bronchoscopy or allergies to medications required for bronchoscopy (i.e. lidocaine, atropine, benzodiazepines); 20. Suffering from major diseases (such as active malignant tumors, multiple organ failure, etc.), the expected survival time is not more than 12 months; 21. Pregnant and lactating women or those planning to become pregnant; 22. Currently participating in any clinical studies of other drugs or medical devices; 23. There are other conditions that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in COPD assessment test (CAT) scores from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Moderate and severe chronic obstructive pulmonary disease exacerbation rate;Incidence of device-related adverse events (AES) and serious adverse events (SAE); | — |
Countries
China
Contacts
Public ContactEnguo Chen
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed