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

Официальное название

A Multi-center, Randomized Controlled Study to Evaluate the Efficacy and Safety of Precise Subsegmental Treatment With InterVapor for Severe Emphysema

Обзор

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

Вмешательства

• Процедура 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 volu

Первичные конечные точки

• Improvement in FEV1 [Срок оценки: 6 months following the second procedure]

Вторичные конечные точки (12)

• Changes in lung volumes by HRCT [Срок оценки: 6 and 12 months following the second procedure]
• Changes in FEV1 [Срок оценки: 12 months following the second procedure]
• Changes in Quality-of-Life score [Срок оценки: 6 and 12 months following the second procedure]
• Changes in FVC [Срок оценки: 6 and 12 months following the second procedure]
• Changes in RV [Срок оценки: 6 and 12 months following the second procedure]
• Changes in TLC [Срок оценки: 6 and 12 months following the second procedure]
• Changes in RV/TLC [Срок оценки: 6 and 12 months following the second procedure]
• Changes in DLCO [Срок оценки: 6 and 12 months following the second procedure]
• Changes in 6MWD [Срок оценки: 6 and 12 months following the second procedure]
• Changes in CAT [Срок оценки: 6 and 12 months following the second procedure]
• Changes in mMRC [Срок оценки: 6 and 12 months following the second procedure]
• A binary responder rate analysis will be performed to determine Minimal Clinically Important Difference (MCID) [Срок оценки: 6 and 12 months following the second procedure]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 9 центров

• Henan Provincial People's Hospital — Чжэнчжоу
• Emergency General Hospital — Пекин
• West China Hospital of Sichuan University — Чэнду
• Linyi People's Hospital — Linyi
• Jiangxi Provincial People's Hospital — Nanchang
• Shanghai Chest Hospital — Шанхай
• Shanghai Sixth People's Hospital — Шанхай
• Hebei Provincial People's Hospital — Shijiazhuang
• … и ещё 1 центр

Публикации

• 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
• 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
• 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
• 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. PMID 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. PMID 41067776

Идентификаторы

NCT: NCT06152107 · IS23073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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