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

Not yet recruiting

• Conditions: Heterogeneous Emphysema

• Registration Number: NCT06642038
• Lead Sponsor: Ye Gu

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-29
• Status Verified: 2024-10
• Study Start: 2024-10-13
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-15
• Primary Completion: 2025-09-01
• Study Completion: 2026-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 51

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) > 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The forced expiratory volume in one second (FEV1) is used to assess lung function	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.	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.

Secondary Outcome Measures

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