Severe EmphysemaBTVANCT06152107
A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema
A study testing BTVA treatment plus optimal medical therapy (GOLD guidelines) in people with Severe Emphysema, run by Shanghai Chest Hospital at 9 sites in China.
Trial summary
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Emphysema
- What is being tested?
- BTVA treatment plus optimal medical therapy (GOLD guidelines)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesChina
- Study dates
- 1 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%);
- 6MWD >140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
- mMRC score≥2;
- Arterial blood gas levels of: PaCO2≤55 mmHg; PaO2>50 mmHg on room air;
- Mentally and physically able to cooperate with the study procedures and to provide informed consent prior to study enrollment.
Who cannot join
- 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;
Show all 14Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Huan Hou, MD., PhD. contact
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
Emergency General Hospital
Beijing, 100028
Yunzhi Zhou, zhouyunzhi2017@126.com
- Not yet recruiting
West China Hospital of Sichuan University
Chengdu, 610041
Dan Liu, liudanscu@qq.com
- Not yet recruiting
Linyi People's Hospital
Linyi
Li Wei, weili68219@163.com
- Not yet recruiting
Jiangxi Provincial People's Hospital
Nanchang
Xiya Wu, sunwuxy@126.com
- Recruiting
Shanghai Chest Hospital
Shanghai, 200030
Jiayuan Sun, MD., PhD, 86-021-22200000, jysun1976@163.com
- Not yet recruiting
Shanghai Sixth People's Hospital
Shanghai
Yi Lu, Luyi0718@126.com
- Not yet recruiting
Hebei Provincial People's Hospital
Shijiazhuang
Yanfeng Gao, 372457953@qq.com
- Recruiting
Sir Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine
Zhejiang, 310009
Enguo Chen, cegsrrsh@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Xiaoju Zhang, zhangxiaoju@zzu.edu.cn
About this study
Official title: A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
- Conditions
- Severe Emphysema
- Being tested
- BTVA treatment plus optimal medical therapy (GOLD guidelines)
- Keywords
- Bronchoscopic Thermal Vapor Ablation (BTVA), Chronic obstructive pulmonary disease (COPD), Severe emphysema, Bronchoscopic lung volume reduction (BLVR)
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTVA treatment plus optimal medical therapy (GOLD guidelines)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines) |
| 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. Receives: Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in FEV1
Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure
Measured: 6 months following the second procedure
Secondary outcomes (13)
Changes in lung volumes by HRCT
Changes in lung volumes from baseline as assessed by HRCT at 6,12 months
Measured: 6 and 12 months following the second procedure
Changes in FEV1
Changes in FEV1 from baseline at 12 months
Measured: 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
Measured: 6 and 12 months following the second procedure
Changes in FVC
Changes in FVC from baseline at 6,12 months
Measured: 6 and 12 months following the second procedure
Changes in RV
Changes in RV from baseline at 6,12 months: RV
Measured: 6 and 12 months following the second procedure
Changes in TLC
Changes in TLC from baseline at 6,12 months
Measured: 6 and 12 months following the second procedure
Changes in RV/TLC
Changes in RV/TLC from baseline at 6,12 months
Measured: 6 and 12 months following the second procedure
Changes in DLCO
Changes in DLCO from baseline at 6,12 months
Measured: 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)
Measured: 6 and 12 months following the second procedure
Changes in CAT
Changes in CAT from baseline at 6,12 months
Measured: 6 and 12 months following the second procedure
Changes in mMRC
Changes in mMRC from baseline at 6,12 months
Measured: 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
Measured: 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
Measured: during or within 12 months after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Severe EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152107
- Sponsor's protocol ID
- IS23073
- Acronym
- BTVA
- Status last verified
- Aug 2025
- First submitted
- 16 Nov 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29895029Shah 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 27693408Bandyopadhyay 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 25500669Yang 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 41878299Yang 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema
- ClinicalTrials.gov ID
- NCT06152107
- Acronym / sponsor ID
- BTVA / IS23073
- Conditions
- Severe Emphysema
- Keywords
- Bronchoscopic Thermal Vapor Ablation (BTVA), Chronic obstructive pulmonary disease (COPD), Severe emphysema, Bronchoscopic lung volume reduction (BLVR)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines) | Experimental | 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) per single procedure. |
| segmental BTVA treatment plus optimal medical therapy (GOLD guidelines) | Active comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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%);
- 6MWD >140 meters (patients with lower limb disability or motor dysfunction will be exempted from the test)
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | segmental BTVA treatment plus optimal medical therapy (GOLD guidelines), subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines) |
Primary outcome
Improvement in FEV1
Time frame: 6 months following the second procedure
Improvement in FEV1 between experimental group vs control group at 6 months following the second procedure
13 secondary outcomes
Changes in lung volumes by HRCT
Time frame: 6 and 12 months following the second procedure
Changes in FEV1
Time frame: 12 months following the second procedure
Changes in Quality-of-Life score
Time frame: 6 and 12 months following the second procedure
Changes in FVC
Time frame: 6 and 12 months following the second procedure
Changes in RV
Time frame: 6 and 12 months following the second procedure
Changes in TLC
Time frame: 6 and 12 months following the second procedure
Changes in RV/TLC
Time frame: 6 and 12 months following the second procedure
Changes in DLCO
Time frame: 6 and 12 months following the second procedure
Changes in 6MWD
Time frame: 6 and 12 months following the second procedure
Changes in CAT
Time frame: 6 and 12 months following the second procedure
Changes in mMRC
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)
Time frame: 6 and 12 months following the second procedure
Incidence of Adverse Events
Time frame: during or within 12 months after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Background: PubMed 29895029Gompelmann 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.
- Background: PubMed 27693408Shah 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.
- Background: PubMed 25500669Bandyopadhyay 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.
- Derived from this study: PubMed 41878299Yang 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.
- Derived from this study: PubMed 41067776Yang 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.
- Individual participant dataSharing planned: No
Related trials for Severe Emphysema
RecruitingObservational study
STRIVE Post-Market Registry Study
Emphysema
Recruiting
A Multi Center Study Testing a New Implant for Adults With Severe Emphysema
Emphysema or COPD, Emphysema
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
Not yet recruitingPhase 1/2
A Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CTX460 in Adults With Emphysema Associated With Severe Alpha-1 Antitrypsin Deficiency (AATD)
Alpha-1 Antitrypsin Deficiency (AATD)
RecruitingPhase 1/2
A Study of TSRA-196 in Adults With PiZZ Alpha-1 Antitrypsin Deficiency (AATD)
Alpha-1 Antitrypsin Deficiency (AATD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huan Hou, MD., PhD. contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTVA treatment plus optimal medical therapy (GOLD guidelines) in people with Severe Emphysema, run by Shanghai Chest Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiayuan Sun, MD., PhD. (86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in FEV1 (time frame: 6 months following the second procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06152107, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.