Efficacy and Safety of Transbronchial BTVA in Heterogeneous Emphysema: A Prospective, Single-Arm, Multicenter Clinical Study
Study Type
OBSERVATIONAL
Enrollment
51
Transbronchial Endoscopic Thermal Vapor Ablation
The forced expiratory volume in one second (FEV1) is used to assess lung function
Evaluate the improvement in FEV1 from baseline to 6 months after BTVA treatment.
Time frame: 6 months
The Saint George's Respiratory Questionnaire-C (SGRQ-C) questionnaire was used to evaluate the value of patients' quality of life.
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.
Time frame: 6 months
FEV1 is used to assess lung function
Improvement in FEV1 12 months after the first treatment.
Time frame: 12 months
The SGRQ-C questionnaire was used to evaluate the value of patients' quality of life.
Improvement in SGRQ-C 12 months after the first 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.
Time frame: 12 months
Forced expiratory volume in one second/Forced vital capcacity(FEV1/FVC) were used to assess lung function
Improvement in FEV1/FVC compared to baseline at 6 and 12 months after the first treatment
Time frame: 6 and 12 months
FVC were used to assess lung function
Improvement in FVC compared to baseline at 6 and 12 months after the first treatment
Time frame: 6 and 12 months
ResidualVolume (RV) were used to assess lung function
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Improvement in RV compared to baseline at 6 and 12 months after the first treatment
Time frame: 6 and 12 months
Total Lung Capacity(TLC) were used to assess lung function
Improvement in TLC compared to baseline at 6 and 12 months after the first treatment
Time frame: 6 and 12 months
6 minute walking distance (6MWD) was used to assess exercise tolerance
Improvement in exercise tolerance compared to baseline at 6 and 12 months after the first treatment: 6MWD.
Time frame: 6 and 12 months
Symptom scoring using COPD Assessment Test (CAT), modified Medical Research Council (mMRC) scoring table
Improvement in symptom scores compared to baseline at 6 and 12 months after the first treatment: CAT, mMRC. The CAT score is a comprehensive assessment of symptoms, ranging from 0 to 40 points. A score of 10 or above indicates a higher number of symptoms. Scores between 0 and 10 reflect a mild impact, 11 to 20 indicate a moderate impact, 21 to 30 represent a severe impact, and 31 to 40 signify a very severe impact on the patient's condition. The mMRC score is a scale used to assess the degree of breathlessness, with a range from 0 to 4. A higher score indicates greater severity of symptoms. A score of 0 reflects no breathlessness except with strenuous exercise, 1 indicates breathlessness when hurrying on level ground or walking up a slight hill, 2 represents breathlessness causing the patient to walk slower than people of the same age or having to stop for breath when walking at their own pace, 3 indicates stopping for breath after walking about 100 meters or after a few minutes on le
Time frame: 6 and 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
All adverse events during surgery and postoperative follow-up were recorded and evaluated according to CTCAE V5.0. The relevance of these events to BTVA treatment was assessed, and the incidence of adverse events and serious adverse events related to BTVA treatment was calculated.
Time frame: At surgery and 12 months after surgery