A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
ConditionSevere Emphysema
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Chest Hospital
About this trial
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Eligibility criteria
Qualifiers
Age≥18 years old;
Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
Disqualifiers
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;
Use of morphine derivatives within 4 weeks prior to screening;
Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
Recent COPD exacerbation in preceding 6 weeks;
Trial design
Treatments tested in this trial
- BTVA treatment plus optimal medical therapy (GOLD guidelines)
Treatment groups
100 Participants
are divided into 2 treatment groupsLocations
9Henan Provincial People's Hospital450003, ZhengzhouHenan, China
Emergency General Hospital100028, Beijing China
West China Hospital of Sichuan University610041, Chengdu China
Linyi People's Hospital Linyi China
Sponsors and collaborators
Shanghai Chest Hospital
Lead sponsor
Source ClinicalTrials.gov