NCT06642038尚未招募不适用
Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
Ye Gu0 个研究点目标入组 51 人开始时间: 2024年10月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 51
- 主要终点
- The forced expiratory volume in one second (FEV1) is used to assess lung function
研究概览
简要总结
Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
The forced expiratory volume in one second (FEV1) is used to assess lung function
时间窗: 6 months
Evaluate the improvement in FEV1 from baseline to 6 months after BTVA treatment.
The Saint George's Respiratory Questionnaire-C (SGRQ-C) questionnaire was used to evaluate the value of patients' quality of life.
时间窗: 6 months
Evaluate the improvement in SGRQ-C questionnaire from baseline to 6 months after BTVA treatment. The total score of SGRQ-C questionnaire usually ranges from 0 to 100, with 0 representing the best condition and 100 representing the worst condition.
次要结局
- FEV1 is used to assess lung function(12 months)
- The SGRQ-C questionnaire was used to evaluate the value of patients' quality of life.(12 months)
- Forced expiratory volume in one second/Forced vital capcacity（FEV1/FVC） were used to assess lung function(6 and 12 months)
- FVC were used to assess lung function(6 and 12 months)
- ResidualVolume (RV) were used to assess lung function(6 and 12 months)
- Total Lung Capacity（TLC） were used to assess lung function(6 and 12 months)
- 6 minute walking distance (6MWD) was used to assess exercise tolerance(6 and 12 months)
- Symptom scoring using COPD Assessment Test (CAT), modified Medical Research Council （mMRC） scoring table(6 and 12 months)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(At surgery and 12 months after surgery)
研究者
Ye Gu
Principal Investigator
Shanghai Pulmonary Hospital, Shanghai, China
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