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

NCT06152107 | Recruiting

• 1 other identifier: IS23073
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Severe Emphysema

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Changes in lung volumes by HRCT

  6 and 12 months following the second procedure

• Changes in FEV1

  12 months following the second procedure

• Changes in Quality-of-Life score

  6 and 12 months following the second procedure

• Changes in FVC

  6 and 12 months following the second procedure

• Changes in RV

  6 and 12 months following the second procedure

Study Arms (2)

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.

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.

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

Interventions

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.

segmental BTVA treatment plus optimal medical therapy (GOLD guidelines); subsegmental BTVA treatment plus optimal medical therapy (GOLD guidelines)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• %predicted≤FEV1≤50%predicted, TLC≥100% predicted, RV≥150% predicted (and RV/ TLC≥55%);
• MWD \>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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (9)

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

Related Publications (4)

• 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.

  PMID: 29895029 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.

  PMID: 27693408 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.

  PMID: 25500669 BACKGROUND

• 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.

  PMID: 41067776 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Jiayuan Sun, MD., PhD.

CONTACT

86-021-22200000; jysun1976@163.com

Huan Hou, MD., PhD.

CONTACT

2298544599@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Respiratory Endoscopy, Shanghai Chest Hospital

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)