Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema

Inclusion criteria

• Male or female, age ≥40 and ≤75 years old
• Heterogeneous emphysema
• 20% predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
• 6-minute walking distance (6MWD) > 140m
• mMRC index ≥ 2
• The patients have fully understood the content of the trial and voluntarily signed the informed consent form

Exclusion criteria

• Contraindications to bronchoscopy include: myocardial infarction within the past month, active massive hemoptysis, coagulation dysfunction, pregnancy, malignant arrhythmia, severe pulmonary hypertension, extreme systemic failure, and other conditions
• Concomitant diseases that may significantly increase the risk of complications after BTVA treatment include, but are not limited to: immune system disorders, bleeding disorders, unstable cardiovascular disease, a history of asthma, and alpha-1 antitrypsin deficiency
• Concomitant medications known to significantly increase the risk of complications after BTVA treatment include, but are not limited to: immunosuppressive drugs (except topical medications), anticoagulants, and antiplatelet drugs
• Receiving morphine derivatives within 4 weeks prior to screening
• Respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (COPD) within 6 weeks prior to screening
• The upper and lower lobes of the other lung have high-grade emphysematous lesions, defined as HRCT showing that the low-density attenuation area (less than -950 Hu) accounts for more than 40% of the total lung volume.
• The lobe of the lung where the intended treatment segment is located has large bullae (defined as bullae that occupy more than one-third of the lobe) or paralobular septal emphysema.
• Symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.).
• Patients who have undergone or plan to undergo lung or chest surgery during this study, including but not limited to lung resection or lung transplantation.
• Patients evaluated by specialists to have highly suspected malignant pulmonary nodules.
• Women who intend to become pregnant, are pregnant, or are breastfeeding during the study.
• Patients participating in other drug or medical device clinical trials.
• The investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.