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

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

Study Overview

• Status: Recruiting
• Conditions: Severe Emphysema
• Intervention / Treatment: Procedure: BTVA treatment plus optimal medical therapy (GOLD guidelines)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiayuan Sun, MD., PhD.; Phone Number: 1511 86-021-22200000; Email: jysun1976@163.com
• Study Contact Backup: Name: Huan Hou, MD., PhD.; Email: 2298544599@qq.com

Study Locations

• China
  • Beijing, China, 100028
    • Not yet recruiting
    • Emergency General Hospital
    • Contact: Yunzhi Zhou; Email: zhouyunzhi2017@126.com
  • Chengdu, China, 610041
    • Not yet recruiting
    • West China Hospital of Sichuan University
    • Contact: Dan Liu; Email: liudanscu@qq.com
  • Linyi, China
    • Not yet recruiting
    • Linyi people's hospital
    • Contact: Li Wei; Email: weili68219@163.com
  • Nanchang, China
    • Not yet recruiting
    • Jiangxi Provincial People's Hospital
    • Contact: Xiya Wu; Email: sunwuxy@126.com
  • Shanghai, China, 200030
    • Recruiting
    • Shanghai Chest Hospital
    • Contact: Jiayuan Sun, MD., PhD; Phone Number: 86-021-22200000; Email: jysun1976@163.com
  • Shanghai, China
    • Not yet recruiting
    • Shanghai Sixth People's Hospital
    • Contact: Yi Lu; Email: Luyi0718@126.com
  • Shijiazhuang, China
    • Not yet recruiting
    • Hebei Provincial People's Hospital
    • Contact: Yanfeng Gao; Email: 372457953@qq.com
  • Zhejiang, China, 310009
    • Recruiting
    • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
    • Contact: Enguo Chen; Email: cegsrrsh@163.com
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Xiaoju Zhang; Email: zhangxiaoju@zzu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 16, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Chronic obstructive pulmonary disease (COPD); Bronchoscopic Thermal Vapor Ablation (BTVA); Severe emphysema; Bronchoscopic lung volume reduction (BLVR)
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Emphysema
• Other Study ID Numbers: IS23073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No