Overview

To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema

Eligibility

Inclusion Criteria:

1. Age≥18 years old;
2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
5. 6MWD >140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
6. mMRC score≥2;
7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2>50 mmHg on room air;
8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.

Exclusion Criteria:

1. Contraindications to bronchoscopy, such as:

   Prior myocardial infarction within 1 month, unstable myocardial ischaemia, ejection fraction (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc;

2. Concomitant illnesses or medications that would pose a significant increased risk for complications following treatment with InterVapor. Examples of particular relevance include: immune system disorders, immunosuppressant medications of clinical relevance, bleeding disorders and unstable cardiovascular conditions, history of asthma or alpha-1 antitrypsin deficiency;
3. Use of morphine derivatives within 4 weeks prior to screening;
4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
5. Recent COPD exacerbation in preceding 6 weeks;
6. Severe emphysema in both the upper and lower lobes of the contralateral lungs, defined as %LAA-950 assessed by HRCT as a percentage of whole lung lobe volume > 40%;
7. Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
9. History of heart and/or lung transplant, lung volume reduction surgery (LVRS), median sternotomy, bullectomy, thoracic surgery with removal of lung tissue and endobronchial lung volume reduction (via valves, coils, stents, etc.);
10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
11. Pregnant or breastfeeding;
12. Current enrollment in any other investigational study which has not completed requisite follow-up;
13. Any conditions assessed by investigator that make patients inappropriate for enrolment.