Clinical trial NCT06642038: Efficacy and Safety of Transbronchial Bronchoscopic Thermal Vapor Ablation (BTVA) in Heterogeneous Emphysema
Official title: Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heterogeneous Emphysema
Keywords: BTVA
Heterogeneous emphysema
Bronchoscopy
Efficacy and Safety
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: First Hospital of China Medical University
name: The First Affiliated Hospital of Zhengzhou University
name: Wuhan Union Hospital, China
name: Shandong Provincial Public Health Clinical Center
name: First Affiliated Hospital, Sun Yat-Sen University
name: Zhongda Hospital
name: Jiangxi Provincial People's Hopital
name: Shenzhen Baoan District People 's Hospital
name: Fifth Affiliated Hospital, Sun Yat-Sen University
name: First Affiliated Hospital of Chongqing Medical University
First posted: 2024-10-15
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are planning to receive BTVA for heterogeneous emphysema

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


Eligibility criteria: Inclusion Criteria:

1. Male or female, age ≥40 and ≤75 years old
2. Heterogeneous emphysema
3. 20% predicted value ≤ FEV1 ≤ 50% predicted value, TLC ≥ 100% predicted value, RV ≥ 150% predicted value, DLCO ≥ 20% predicted value
4. 6-minute walking distance (6MWD) \&gt; 140m
5. mMRC index ≥ 2
6. The patients have fully understood the content of the trial and voluntarily signed the informed consent form

Exclusion Criteria:

1. 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
2. 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
3. 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
4. Receiving morphine derivatives within 4 weeks prior to screening
5. Respiratory tract infection or exacerbation of chronic obstructive pulmonary disease (COPD) within 6 weeks prior to screening
6. 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.
7. 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.
8. Symptoms or abnormal laboratory values suggesting active infection (e.g., fever, elevated white blood cell count, etc.).
9. 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.
10. Patients evaluated by specialists to have highly suspected malignant pulmonary nodules.
11. Women who intend to become pregnant, are pregnant, or are breastfeeding during the study.
12. Patients participating in other drug or medical device clinical trials.
13. The investigator believes the patient has other conditions that make them unsuitable for inclusion in this study.

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