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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BTVA treatment plus optimal medical therapy (GOLD guidelines)
Procedure/SurgeryPatients in experimental group will be treated with the InterVapor System in at least 2 subsegments of different segments(unless the two most severe subsegments are located in the same segment). Patients in control group will be treated with the InterVapor System in at least 1 segment. A sequential procedure allows for at least 6 weeks and no longer than 6 months after the first procedure. Patients in both groups will receive ipsilateral hemithorax treatment per procedure, with a treatment volume (air + tissue) of ≤1700 mL per procedure and ≥1000 mL cumulatively across two procedures. All patients will continue to receive optimal medical therapy (GOLD guidelines) for the duration of the study. Follow-up visits will be scheduled at 1, 3, 6 and 12 months following the second procedure with examination of pulmonary function tests, HRCT, 6-minute walk test, SGRQ-C, mMRC, CAT questionnaires. All adverse events during the study will be recorded.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines)Experimental treatment 1 intervention
Group B: segmental BTVA treatment plus optimal medical therapy (GOLD guidelines)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Improvement in FEV1
Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure
Time frame
6 months following the second procedureSecondary outcomes
1
Changes in lung volumes by HRCT
Changes in lung volumes from baseline as assessed by HRCT at 6,12 months
Time frame
6 and 12 months following the second procedure2
Changes in FEV1
Changes in FEV1 from baseline at 12 months
Time frame
12 months following the second procedure3
Changes in Quality-of-Life score
Changes in Quality-of-Life score as assessed by the SGRQ-C questionnaire from baseline at 6,12 months
Time frame
6 and 12 months following the second procedure4
Changes in FVC
Changes in FVC from baseline at 6,12 months
Time frame
6 and 12 months following the second procedureSponsors and contacts
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Source ClinicalTrials.gov