Chronic obstructive pulmonary disease
Conditions
Interventions
group 1:Unipolar cumulative ablation energy 1080j for bilateral main bronchus (or lobar bronchus) nerve ablation
group 2:Unipolar cumulative ablation energy 1260j for bilateral main bronchus (or lobar bronchus) nerve ablation
group 3:Unipolar cumulative ablation energy 1440j ) for bilateral main bronchus (or lobar bronchus) nerve ablation
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. When signing the informed consent, the aged 40 to 75 years; 2. Women of reproductive potential must have a negative pregnancy test (serum or urine) at screening, and have no plans to become pregnant during the study period; 3. Not smoking for at least 2 months prior to informed consent and agree not to smoke during the study. If the participant is taking smoking cessation medications, cessation patches, chewing gum, etc., quantitative testing should be performed to assess whether measured levels of nicotine or cotinine are below study thresholds; 4. SpO2>=89% when breathing air at sea level during screening; 5. CAT score >= 10 or mMRC >= 2 at screening; 6. According to the 2021 edition of GOLD, a definite diagnosis of COPD, 20%<=FEV1% predicted value <60%,; 7. Record at least a history of taking ICS+LABA and LAMA+LABA as routine respiratory maintenance drugs for at least 12 months at the time of informed consent; 8. The patient is a candidate for bronchoscopy based on physician judgment or hospital guidelines. Examples of participants who are candidates for bronchoscopy include, but are not limited to: cardiovascular health, patient can be intubated, oxygen is available, no prior diagnosis of severe tracheal obstruction, no uncorrectable coagulopathy (i.e. participating patients can be intubated within 7 days prior to surgery). Stop taking anticoagulant and antiplatelet medications other than aspirin and meet the requirement to restart until 7 days after study surgery); 9. Willing, able, and agreeing to complete baseline and follow-up testing assessments required for all protocols, including taking certain medications (eg, azithromycin, prednisolone/prednisone, etc.).
Exclusion criteria
Exclusion criteria: 1. BMI index 35 kg/m2; 2. The patient has implanted electronic devices; 3. Uncontrollable diabetes, such as HbA1c>7%; 4. There are pulmonary nodules that are highly suspected to be malignant; 5. Received surgery, radiotherapy or chemotherapy for malignant tumor, and other thoracic surgery within the past 2 years at the time of informed consent; 6. Informed consent for more than 3 respiratory-related hospitalizations in the past 1 year; 7. Asthma defined according to current GINA guidelines; 8. The patient has been diagnosed with non-COPD lung disease or has a history of pneumothorax; 9. Clinically relevant bronchiectasis, defined as severe single- or multi-lobe bronchial wall thickening, associated with airway dilation on CT scan, resulting in a cough that persists for several days and intractable expectoration; 10. Previous diagnosis of pulmonary hypertension, defined as echocardiography? Estimated pulmonary artery systolic blood pressure greater than 70mmHg; 11. Myocardial infarction within the past 6 months, EKG (electrocardiogram) showing evidence of life-threatening arrhythmia or acute ischemia, previous LVEF=18.0 before treatment; 14. Patients with scar constitution; 15. The patient has any disease or condition that the investigator assesses may interfere with the operation or completion of the study (such as esophageal disease, life expectancy 10mg of prednisone or its equivalent per day; 17. Opioid use within 3 months before informed consent; 18. Known contraindications or drug allergies to the required bronchoscopy or general anesthesia, which cannot be controlled by drugs; 19. Chest CT at screening shows bronchial anatomy that prevents adequate treatment with existing catheters, such as adjacent severe bullae (>1/3 unilateral lung), or a mass requiring treatment at the treatment site; 20. The investigator assesses that the use of a targeted lung denervation ablation system is not technically feasible due to patient anatomy or other clinical findings; 21. Patients are currently or plan to take non-COPD disease-related drugs that act on the M receptor mechanism at the time of screening, such as male patients who use M receptor blockers for prostate or bladder disease, and cannot be discontinued for at least 1 prior to planned surgery. days (short-acting drugs) or 7 days (long-acting drugs); 22. Participating in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any suspected or identified adverse events and serious adverse events related to the device or operation;Device success rate;Technical success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes compared to baseline pulmonary function tests;Changes compared to baseline - motor ability;Changes relative to baseline - health-related quality of life and other COPD related scores;Success rate of immediate operation;Incidence of acute exacerbation of moderate and severe COPD (AECOPD);Perioperative mortality;Change compared to baseline - sputum volume within 1 hour of morning rise during follow-up; ?????????? Occurrence of all adverse events; | — |
Countries
China
Contacts
Public ContactLuo Fengming
West China Hospital of Sichuan University
Outcome results
None listed