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RecruitingNCT06152107BTVAUpdated Sep 8, 2025

A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema

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

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema

02

Conditions studied

  • Severe Emphysema

Keywords

  • Bronchoscopic Thermal Vapor Ablation (BTVA)
  • Chronic obstructive pulmonary disease (COPD)
  • Severe emphysema
  • Bronchoscopic lung volume reduction (BLVR)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age≥18 years old;
  2. Patients with severe emphysema and with at least two treatable subsegments and 1 treatable segment in the ipsilateral lung assessed by QCT;
  3. Non-smoking for 2 months prior to study enrollment, and remain abstinent from smoking for the duration of the study;
  4. 15%predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
  5. 6MWD >140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
  6. mMRC score≥2;
  7. Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2>50 mmHg on room air;
  8. Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.

Exclusion criteria

Exclusion Criteria:

  1. 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;

  2. 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;
  3. Use of morphine derivatives within 4 weeks prior to screening;
  4. Taking more than 10 mg prednisolone or equivalent daily glucocorticoids at the screening visit;
  5. Recent COPD exacerbation in preceding 6 weeks;
  6. 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%;
  7. Presence of single large bulla (defined as > 1/3 volume of lobe) or a paraseptal distribution of emphysema in the target lobe;
  8. Presence of active pathogen related infection or symptoms indicative of active infection (e.g. fever, elevated WBC, etc.);
  9. 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.);
  10. Highly suspicious malignant pulmonary nodules in the lungs as assessed by specialist;
  11. Pregnant or breastfeeding;
  12. Current enrollment in any other investigational study which has not completed requisite follow-up;
  13. Any conditions assessed by investigator that make patients inappropriate for enrolment.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    subsegmental 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) per single procedure.

    Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)

  • Active comparator
    segmental 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)

Interventions

  • ProcedureBTVA 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.

05

What researchers measure

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 procedure

Secondary 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 procedure

  2. Changes in FEV1

    Changes in FEV1 from baseline at 12 months

    Time frame: 12 months following the second procedure

  3. 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

  4. Changes in FVC

    Changes in FVC from baseline at 6,12 months

    Time frame: 6 and 12 months following the second procedure

  5. Changes in RV

    Changes in RV from baseline at 6,12 months: RV

    Time frame: 6 and 12 months following the second procedure

  6. Changes in TLC

    Changes in TLC from baseline at 6,12 months

    Time frame: 6 and 12 months following the second procedure

  7. Changes in RV/TLC

    Changes in RV/TLC from baseline at 6,12 months

    Time frame: 6 and 12 months following the second procedure

  8. Changes in DLCO

    Changes in DLCO from baseline at 6,12 months

    Time frame: 6 and 12 months following the second procedure

  9. 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

  10. Changes in CAT

    Changes in CAT from baseline at 6,12 months

    Time frame: 6 and 12 months following the second procedure

  11. Changes in mMRC

    Changes in mMRC from baseline at 6,12 months

    Time frame: 6 and 12 months following the second procedure

  12. 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

  13. 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

06

Study locations

3 of 9 sites recruiting
  • Henan Provincial People's Hospital
    Zhengzhou, Henan 450003, China
    Recruiting
  • Emergency General Hospital
    Beijing, 100028, China
    Not yet recruiting
  • West China Hospital of Sichuan University
    Chengdu, 610041, China
    Not yet recruiting
  • Linyi People's Hospital
    Linyi, China
    Not yet recruiting
  • Jiangxi Provincial People's Hospital
    Nanchang, China
    Not yet recruiting
  • Shanghai Chest Hospital
    Shanghai, 200030, China
    Recruiting
  • Shanghai Sixth People's Hospital
    Shanghai, China
    Not yet recruiting
  • Hebei Provincial People's Hospital
    Shijiazhuang, China
    Not yet recruiting
  • Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
    Zhejiang, 310009, China
    Recruiting
07

References and documents

Publications

  • 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. PubMed 29895029 ↗
  • 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. PubMed 27693408 ↗
  • 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. PubMed 25500669 ↗
  • 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. PubMed 41878299 ↗
  • 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. PubMed 41067776 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06152107
Lead sponsor
Shanghai Chest Hospital
Responsible party
Jiayuan Sun (Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital, Shanghai Chest Hospital) — Principal investigator
First posted
Nov 30, 2023
Start date
Jan 1, 2024
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 8, 2025

Study contacts

Jiayuan Sun, MD., PhD.
Contact
jysun1976@163.com
86-021-22200000 ext. 1511
Huan Hou, MD., PhD.
Contact
2298544599@qq.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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