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Набор скоро начнётся NCT06642038

Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema

— Наблюдательное Heterogeneous Emphysema

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transbronchial Endoscopic Thermal Vapor Ablation.
Кому может быть актуально
Состояния в реестре: Heterogeneous Emphysema. Базовые параметры: 40 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study

Обзор

Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study

Вмешательства

  • Процедура Transbronchial Endoscopic Thermal Vapor Ablation
    Transbronchial Endoscopic Thermal Vapor Ablation

Первичные конечные точки

  • The forced expiratory volume in one second (FEV1) is used to assess lung function [Срок оценки: 6 months]
  • The Saint George's Respiratory Questionnaire-C (SGRQ-C) questionnaire was used to evaluate the value of patients' quality of life. [Срок оценки: 6 months]
Вторичные конечные точки (9)
  • FEV1 is used to assess lung function [Срок оценки: 12 months]
  • The SGRQ-C questionnaire was used to evaluate the value of patients' quality of life. [Срок оценки: 12 months]
  • Forced expiratory volume in one second/Forced vital capcacity（FEV1/FVC） were used to assess lung function [Срок оценки: 6 and 12 months]
  • FVC were used to assess lung function [Срок оценки: 6 and 12 months]
  • ResidualVolume (RV) were used to assess lung function [Срок оценки: 6 and 12 months]
  • Total Lung Capacity（TLC） were used to assess lung function [Срок оценки: 6 and 12 months]
  • 6 minute walking distance (6MWD) was used to assess exercise tolerance [Срок оценки: 6 and 12 months]
  • Symptom scoring using COPD Assessment Test (CAT), modified Medical Research Council （mMRC） scoring table [Срок оценки: 6 and 12 months]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: At surgery and 12 months after surgery]

Критерии участия

Критерии включения

  • Male or female, age ≥40 and ≤75 years old
  • Heterogeneous emphysema
  • 20% predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
  • 6-minute walking distance (6MWD) \> 140m
  • mMRC index ≥ 2
  • The patients have fully understood the content of the trial and voluntarily signed the informed consent form

Критерии исключения

  • Contraindications to bronchoscopy include: myocardial infarction within the past month, active massive hemoptysis, coagulation dysfunction, pregnancy, malignant arrhythmia, severe pulmonary hypertension, extreme systemic failure, and other conditions
  • Concomitant diseases that may significantly increase the risk of complications after BTVA treatment include, but are not limited to: immune system disorders, bleeding disorders, unstable cardiovascular disease, a history of asthma, and alpha-1 antitrypsin deficiency
  • Concomitant medications known to significantly increase the risk of complications after BTVA treatment include, but are not limited to: immunosuppressive drugs (except topical medications), anticoagulants, and antiplatelet drugs
  • Receiving morphine derivatives within 4 weeks prior to screening
  • Respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (COPD) within 6 weeks prior to screening
  • The upper and lower lobes of the other lung have high-grade emphysematous lesions, defined as HRCT showing that the low-density attenuation area (less than -950 Hu) accounts for more than 40% of the total lung volume.
  • The lobe of the lung where the intended treatment segment is located has large bullae (defined as bullae that occupy more than one-third of the lobe) or paralobular septal emphysema.
  • Symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.).
  • Patients who have undergone or plan to undergo lung or chest surgery during this study, including but not limited to lung resection or lung transplantation.
  • Patients evaluated by specialists to have highly suspected malignant pulmonary nodules.
  • Women who intend to become pregnant, are pregnant, or are breastfeeding during the study.
  • Patients participating in other drug or medical device clinical trials.
  • The investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06642038 · L23-399

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗