An interventional study of BTVA treatment plus optimal medical therapy (GOLD guidelines) in Severe Emphysema, sponsored by Shanghai Chest Hospital. Recruiting at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Shanghai Chest Hospital · Not applicable, Interventional, and Treatment
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 245 interventional studies indexed under Emphysema.
Browse Emphysema studies →Shanghai Chest Hospital is the lead sponsor of 198 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
to bronchoscopy, such as:
Prior myocardial infarction within 1 month, unstable myocardial ischaemia, (EF) ≤ 40%; Active haemoptysis; Coagulation disorders; Malignant cardiac arrhythmia, severe pulmonary hypertension, extreme systemic failure, etc;
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients 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) per single procedure.
Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)
Patients in control group will be treated with the InterVapor System in at least 1 segment per single procedure.
Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)
Patients 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.
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 procedure
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 procedure
Changes in FEV1
Changes in FEV1 from baseline at 12 months
Time frame: 12 months following the second procedure
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 procedure
Changes in FVC
Changes in FVC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in RV
Changes in RV from baseline at 6,12 months: RV
Time frame: 6 and 12 months following the second procedure
Changes in TLC
Changes in TLC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in RV/TLC
Changes in RV/TLC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in DLCO
Changes in DLCO from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in 6MWD
Changes in 6MWD from baseline at 6,12 months (patients with lower limb disability or motor dysfunction will be exempted from the test)
Time frame: 6 and 12 months following the second procedure
Changes in CAT
Changes in CAT from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
Changes in mMRC
Changes in mMRC from baseline at 6,12 months
Time frame: 6 and 12 months following the second procedure
A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID)
A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID) at 6,12 months: %predicted FEV1≥12% difference from baseline SGRQ-C≥8 points difference from baseline 6MWD≥26m from baseline
Time frame: 6 and 12 months following the second procedure
Incidence of Adverse Events
Adverse events related to the procedure during or within 12 months after the operation
Time frame: during or within 12 months after the operation
Plan to share: No
Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.
Of 40 non-industry interventional studies with no phase under Emphysema, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 58. This study's planned 35 months is below that.
Counting every sponsor, half of 60 studies reached it within 37 months; a quarter within 22 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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