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To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines) | Experimental | 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. |
|
| segmental BTVA treatment plus optimal medical therapy (GOLD guidelines) | Active Comparator | Patients in control group will be treated with the InterVapor System in at least 1 segment per single procedure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTVA treatment plus optimal medical therapy (GOLD guidelines) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in FEV1 | Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure | 6 months following the second procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lung volumes by HRCT | Changes in lung volumes from baseline as assessed by HRCT at 6,12 months | 6 and 12 months following the second procedure |
| Changes in FEV1 | Changes in FEV1 from baseline at 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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;
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;
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%;
Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
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.);
Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
Pregnant or breastfeeding;
Current enrollment in any other investigational study which has not completed requisite follow-up;
Any conditions assessed by investigator that make patients inappropriate for enrolment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayuan Sun, MD., PhD. | Contact | 86-021-22200000 | 1511 | jysun1976@163.com |
| Huan Hou, MD., PhD. | Contact | 2298544599@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29895029 | Background | Gompelmann D, Shah PL, Valipour A, Herth FJF. Bronchoscopic Thermal Vapor Ablation: Best Practice Recommendations from an Expert Panel on Endoscopic Lung Volume Reduction. Respiration. 2018;95(6):392-400. doi: 10.1159/000489815. Epub 2018 Jun 12. | |
| 27693408 | Background | Shah PL, Herth FJ, van Geffen WH, Deslee G, Slebos DJ. Lung volume reduction for emphysema. Lancet Respir Med. 2017 Feb;5(2):147-156. doi: 10.1016/S2213-2600(16)30221-1. Epub 2016 Sep 29. |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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|
| 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 | 6 and 12 months following the second procedure |
| Changes in FVC | Changes in FVC from baseline at 6,12 months | 6 and 12 months following the second procedure |
| Changes in RV | Changes in RV from baseline at 6,12 months: RV | 6 and 12 months following the second procedure |
| Changes in TLC | Changes in TLC from baseline at 6,12 months | 6 and 12 months following the second procedure |
| Changes in RV/TLC | Changes in RV/TLC from baseline at 6,12 months | 6 and 12 months following the second procedure |
| Changes in DLCO | Changes in DLCO from baseline at 6,12 months | 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) | 6 and 12 months following the second procedure |
| Changes in CAT | Changes in CAT from baseline at 6,12 months | 6 and 12 months following the second procedure |
| Changes in mMRC | Changes in mMRC from baseline at 6,12 months | 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 | 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 | during or within 12 months after the operation |
| Emergency General Hospital | Not yet recruiting | Beijing | 100028 | China |
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| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | 610041 | China |
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| Linyi People's Hospital | Not yet recruiting | Linyi | China |
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| Jiangxi Provincial People's Hospital | Not yet recruiting | Nanchang | China |
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| Shanghai Chest Hospital | Recruiting | Shanghai | 200030 | China |
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| Shanghai Sixth People's Hospital | Not yet recruiting | Shanghai | China |
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| Hebei Provincial People's Hospital | Not yet recruiting | Shijiazhuang | China |
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| Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine | Recruiting | Zhejiang | 310009 | China |
|
| 25500669 | Background | Bandyopadhyay S, Henne E, Gupta A, Barry R, Snell G, Strange C, Herth FJ. Segmental approach to lung volume reduction therapy for emphysema patients. Respiration. 2015;89(1):76-81. doi: 10.1159/000369036. Epub 2014 Dec 6. |
| 41878299 | Derived | Yang H, Chen S, Zheng X, Cui N, Xie F, Hou H, Ye L, Herth FJF, Sun J. Association Between Subsegmental Dosing Accuracy and Outcomes of Bronchoscopic Thermal Vapor Ablation: An Exploratory Retrospective Study in Severe Heterogeneous Emphysema. Int J Chron Obstruct Pulmon Dis. 2026 Jan 23;21:560457. doi: 10.2147/COPD.S560457. eCollection 2026. |
| 41067776 | Derived | Yang H, Chen S, Ye L, Herth FJ, Sun J. Study protocol for a multicentre, randomised controlled trial in China to evaluate the efficacy and safety of precise subsegmental bronchoscopic thermal vapour ablation treatment in severe emphysema. BMJ Open. 2025 Oct 9;15(10):e099367. doi: 10.1136/bmjopen-2025-099367. |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |