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 groupsSponsors and collaborators
Source ClinicalTrials.gov